Port assembly for an integrated medication delivery system

ABSTRACT

A medication delivery system delivers medication to a patient and is suitable for sterilization by a sterilization fluid. The system includes a base and a reservoir disposed about the base for storing the medication. A pump for delivering the medication to the patient is supported by the base. The pump includes a housing having an inlet and an outlet. The inlet and outlet alternate between an open and a closed state to deliver the medication. A port extends from the base. The port fluidly communicates with the reservoir and the pump during sterilization to provide access for the fluid to flow into the reservoir and the pump. An actuator is disposed in the base. The actuator operatively engages the inlet and outlet to retain them in the open state during sterilization. As such, the fluid can penetrate into the reservoir, the inlet, the housing, and the outlet to sterilize the system.

RELATED APPLICATIONS

[0001] This patent application claims priority to and all advantages ofU.S. Provisional Patent Application Ser. No. 60/271,187 which was filedon Feb. 23, 2001.

FIELD OF THE INVENTION

[0002] The subject invention generally relates to an integratedmedication delivery system for delivering medication to a patient. Theintegrated medication delivery system is primarily used throughout themedical profession to deliver pain control medication and othermedications intra-operatively, subcutaneously, and percutaneously to thepatient to the patient after a surgical, or some other medical,procedure.

BACKGROUND OF THE INVENTION

[0003] Medication delivery systems are known in the art. As indicatedabove, medication delivery systems are used to deliver pain controlmedication and other medications intra-operatively, subcutaneously, andpercutaneously to a patient after a surgical, or some other medical,procedure.

[0004] Conventional medication delivery systems are deficient for onereason or another. For example, U.S. Pat. No. 5,807,075 to Jacobsen etal. discloses a conventional medication delivery system that includes abase housing and a cassette. The base housing of the '075 patent houseselectronic components, such as an electric motor, a power source, and anelectronic controller, and the cassette of the '075 patent interactswith a supply of the medication to deliver the medication to thepatient. This medication delivery system is deficient because the supplyof the medication is not integrated into the cassette. That is, thecassette does not house the supply of the medication. Instead, thesupply is external to the medication delivery system. This medicationdelivery system is also deficient because the base housing and thecassette are not properly integrated. As such, the complete medicationdelivery system, having the base housing and the cassette, cannot besimultaneously sterilized prior to use of the system. Instead, the basehousing and the cassette require separate sterilization. Furthermore,because the base housing and the cassette are not integrated, thecassette must be mounted to the base housing which requires additionalassembly by a surgeon or some other medical assistant. This additionalassembly is time consuming and is often inconvenient for the surgeonsand medical assistants.

[0005] A further example of a conventional medication delivery system isdisclosed in U.S. Pat. No. 4,650,469 to Berg et al. This patentdiscloses a medication delivery system that includes a control moduleand a reservoir module removably connected to the control module. Thecontrol module includes a pump mechanism, valves, a power source,electronic controls, and the like, and the reservoir module includes acontainer that supplies the medication to be delivered to the patient.Although the medication delivery system disclosed in the '469 patentconnects the control module and the reservoir module, this medicationdelivery system is deficient in that, once connected, the control moduleand the reservoir module cannot be simultaneously sterilized. Themodules cannot be simultaneously sterilized because, as described atcolumn 11, lines 22-28, one of the valves in the control module closesthe fluid connection (the tube 22) between the control module and thereservoir module at all times. That is, the '469 patent does not includea device, such as an actuator, to prevent the valves from closing onthis fluid connection. As such, a sterilization fluid, such as ethyleneoxide (EtO) gas cannot flow into both the control module and thereservoir module once these modules are connected.

[0006] The conventional medication delivery system disclosed in the '469patent is also deficient because it relies exclusively on a motor and acam shaft to move the valves from the open position to the closedposition when delivering the medication to the patient. This medicationdelivery system does not incorporate an additional biasing device toensure that the valves are biased into the closed position if the motor,gear, cam shaft, or power supply fails. Without such an additionalbiasing device, this system's ability to prevent the inadvertentdelivery of the medication to the patient in the event of one of theabove failures is compromised. Instead, this medication delivery systemrelies only on the motor and the cam shaft to allow or to preventdelivery of the medication, and reliance on these two components isinsufficient.

[0007] Other conventional medication delivery systems are also deficientfor a multitude of other reasons. For instance, these conventionalsystems do not incorporate port assemblies that adequately control theflow of medication throughout the system. In these conventional systems,a single port assembly does not enable various medical fluids to flowinto, from, and within the system. Conventional medication deliverysystems also do not provide detection systems that adequately determinewhen a medication delivery system is realizing a blockage in the flow ofmedication to the patient or that adequately determine when a supply inthe medication delivery system has been depleted. The detection systemsin the prior art medication delivery systems do not make optimum use ofthe position of the tubes that carry the medication relative to theposition of the electronic controller. Conventional medication deliverysystems also do not provide a testing access port that allowsmanufacturers to confirm operation of the medication delivery systemafter assembly, and prior to use, of the system. As such, the operationof many prior art medication delivery systems cannot be confirmed priorto shipment to medical professionals for use. Conventional medicationdelivery systems are also not ideal for carrying. Some prior art systemsdo not even include a carrying strap. As such, the patient cannot beeasily treated outside of a hospital or other medical facility, thepatient is prevented from being ambulatory. Other medication deliverysystems in the prior art that do include some form of carrying strap donot make carrying convenient because, in these systems, the carryingstrap is not conveniently stored in a storage cavity of the system. Thatis, the carrying strap is not integrated into the system itself for easyaccess by the patient. The medication delivery systems of the prior artare also not easily controlled. That is, there is not method associatedwith these systems that effectively controls an amount of the medicationto be delivered to the patient. The prior art methods for controllingthe amount of medication that is to be delivered to the patient aredeficient because these methods require constant attention, requirecomplicated setup and monitoring by the surgeon or other medicalprofessional, and may even risk the health and safety of the patient.Other conventional medication delivery systems do not have electroniccontrollers, specifically specialized circuitry incorporated into thecontroller, that adequately prevent too much medication from beingdelivered to the patient in the event of failure of certain mechanicalcomponents. Also, the electronic controllers and circuitry of otherconventional medication delivery systems are not suitably designed tomaximize the conservation of power and to prevent the entire medicationdelivery system from being reset by removing and replacing the powersource, e.g. a battery.

[0008] Due to the deficiencies in conventional medication deliverysystems, including those described above, it is desirable to provide anovel medication delivery system that is appropriately integrated forsimultaneous sterilization. It is also desirable to provide a novelmedication delivery system that overcomes the other deficienciesidentified above in the prior art.

SUMMARY OF THE INVENTION AND ADVANTAGES

[0009] An integrated medication delivery system is disclosed. Themedication delivery system delivers medication to a patient. Themedication delivery system is primarily used to deliver pain controlmedication and other medications intraoperatively, subcutaneously, andpercutaneously to the patient after a surgical, or some other medical,procedure. The medication delivery system according to the subjectinvention is suitable for complete sterilization by a sterilizationfluid.

[0010] To accomplish complete sterilization, the medication deliverysystem includes a base housing and a medication reservoir. Themedication reservoir is disposed about the base housing for storing themedication that is to be delivered to the patient. As such themedication reservoir, i.e., the supply of the medication, is integratedwith the base housing.

[0011] The medication delivery system includes a pump assembly fordelivering the medication to the patient. More specifically, the pumpassembly, which is supported by the base housing, includes a pumphousing having a pump inlet and a pump outlet. The pump inlet and thepump outlet alternate between an open and a closed state to deliver themedication the patient. A port extends from the base housing and is influid communication with the medication reservoir and the pump assemblyduring sterilization. As such, the port provides access for thesterilization fluid to flow into the medication reservoir and the pumpassembly.

[0012] The medication delivery system further includes an actuatordisposed in the base housing. The actuator operatively engages the pumpinlet and the pump outlet to retain both the pump inlet and the pumpoutlet in the open state during sterilization. As a result, thesterilization fluid can penetrate into the medication reservoir, thepump inlet, the pump housing, and the pump outlet to completelysterilize the medication delivery system. That is, because of theactuator, the complete medication delivery system of the subjectinvention, including the base housing, the pump assembly, and themedication reservoir can be simultaneously sterilized prior to use ofthe system. Also, because the medication reservoir is disposed about andproperly integrated with the base housing, the supply of the medicationis not external to the rest of the medication delivery system, and themedication delivery system does not require additional assembly by asurgeon and the like prior to use.

[0013] The pump assembly for the medication delivery system also servesto prevent the inadvertent delivery of the medication to the patient. Inaddition to the pump housing, the pump inlet, and the pump outlet, thepump assembly may further include, depending on the particularembodiment, first and second pinch levers and at least one biasingdevice.

[0014] The first pinch lever is disposed at the pump inlet and ismoveable between an open position and a closed position to control aflow of the medication into the pump housing through the pump inlet. Thesecond pinch lever is disposed at the pump outlet and is moveablebetween an open position and a closed position to control a flow of themedication from the pump housing through the pump outlet. A motor, whichoperatively engages the first and second pinch levers, is included tomove the first and second pinch levers into the open position such thatthe medication can delivered to the patient.

[0015] The biasing device engages at least one of the first and secondpinch levers and works in conjunction with the motor to normally bias atleast one of the first and second pinch levers into the closed positionduring delivery of the medication to the patient. This maintains atleast one of the first and second pinch levers in the closed positionduring a failure of the motor thereby preventing the inadvertentdelivery of the medication to the patient. As a result, the medicationdelivery system of the subject invention does not exclusively rely onthe motor to move the valves from the open position to the closedposition when delivering the medication to the patient. That is, thebiasing device ensures that the first and second pinch levers are biasedinto the closed position even if the motor, or other mechanicalcomponents, such as a gear, cam shaft, or power supply, fails. With thebiasing device, the subject invention guarantees prevention of theinadvertent delivery of the medication to the patient in the event ofone of the above failures.

[0016] A port assembly for the medication delivery system may also beincluded to enable various fluids, such as the sterilization fluid andthe medication, to flow into, from, and within the medication deliverysystem. The port assembly includes an elongated housing and a plungerdisposed within the housing. The plunger is moveable within the housingbetween an off-position, a fill-position, and a fluid delivery-position.The flow of the fluids into, from, and within the medication deliverysystem is controlled and modified depending on the position of theplunger. As such, the port assembly provides adequate control of theflow of medication throughout the medication delivery system.

[0017] The subject invention further provides a blockage detectionsystem for the medication delivery system. Utilizing an electroniccontroller, a detection film, and a medication outlet tube, and relyingon expansion of the medication outlet tube in response to increasedpressure in the medication outlet tube, the empty detection systemdetects a blockage in the flow of the medication to the patient. Theempty detection system adequately determines when the medicationdelivery system is realizing a blockage. To accomplish this, the emptydetection system makes optimum use of the position of the medicationoutlet tube relative to the position of the electronic controller. Thedetection film may be replaced with a coating applied to the medicationoutlet tube that activates the electronic controller.

[0018] The subject invention further provides an empty detection systemfor the medication delivery system. Utilizing the electronic controller,the detection film, and a medication inlet tube, and relying on thecollapsibility or contraction of the medication inlet tube in responseto variations in pressure in the medication inlet tube that result froma lack of flow of the medication, the empty detection system detectswhen the supply of the medication has been depleted. To accomplish this,the empty detection system makes optimum use of the position of themedication inlet tube relative to the position of the electroniccontroller. As in the empty detection system, the detection film in theempty detection system may also be replaced with a coating applied tothe medication inlet tube that serves to activate and deactivate theelectronic controller.

[0019] After assembly of the medication delivery system, the subjectinvention can be tested using a testing instrument. To accomplishtesting of the medication delivery system, at least one testing accessport is defined within the base housing. The testing access port isaligned with at least one of the pump inlet, the pump outlet, and theactuator to provide access for the testing instrument. The testinginstrument effectively disengages the actuator from the pump inlet andthe pump outlet such that they can alternate between open and closedstates and the operation of the medication delivery system can betesting with an operable pump assembly. The testing access port,incorporated into the base housing, allows the manufacturer to confirmoperation after assembly, and prior to use, of the medication deliverysystem.

[0020] The medication delivery system of the subject invention is alsoideal for carrying by the patient. A carrying strap is mounted withinthe base housing for the carrying of the medication delivery system bythe patient. More specifically, carrying strap is at least partiallydisposed in an integral storage cavity that is defined within the basehousing. The carrying strap at least partially extends from the integralstorage cavity to interact with the patient for carrying the medicationdelivery system. The carrying strap and integral storage cavity of thesubject invention enable the patient to continue easy treatment outsideof a hospital or other medical facility. As a result, the patient canremain ambulatory. Disposing the carrying strap in the integral storagecavity makes carrying the medication delivery system of the subjectinvention a convenient experience for the patient as the carrying strapis always easily accessible.

[0021] The subject invention further includes a method of controllingthe medication delivery system. The method includes the step ofselecting the amount of the medication that is to be delivered to thepatient in accordance with a first set of explanatory indicia on aremovable overlay label. Next, the system is locked such that theselected amount of the medication to be delivered to the patient isunable to be modified. After the system is locked, the removable overlaylabel is removed to reveal a patient label. Then, the medicationdelivery system is operated in accordance with a second set ofexplanatory indicia on the patient label. This method effectivelycontrols the amount of the medication that is to be delivered to thepatient and also provides for easy control and programming of themedication delivery system. As a result of this method of controllingthe medication delivery system, the patient does not need to constantlypay attention to and maintain the medication delivery system. Also,set-up of the medication delivery system is not complicated andmonitoring of the medication delivery system is not required such thatthe health and safety of the patient is not compromised.

[0022] The subject invention also includes the electronic controller andspecialized circuitry incorporated into the electronic controller forvarious reasons. For instance, some circuitry is targeted to prevent toomuch medication from being delivered to the patient if certainmechanical components fail. Other electronic design features of theelectronic controller of the subject invention are targeted to conservepower throughout the medication delivery system and to prevent theentire medication delivery system from being reset upon the removal orreplacement of the power source.

[0023] Accordingly, the subject invention provides an integratedmedication delivery system that overcomes the deficiencies in the priorart, including those described above.

BRIEF DESCRIPTION OF THE DRAWINGS

[0024] Other advantages of the present invention will be readilyappreciated as the same becomes better understood by reference to thefollowing detailed description when considered in connection with theaccompanying drawings wherein:

[0025]FIG. 1A is a perspective view of an integrated medication deliverysystem according to the subject invention with an infusion tube set;

[0026]FIG. 1B is a perspective view of an underside of the systemillustrating a system mounting clip for securing the system to apatient;

[0027]FIG. 2A is an exploded perspective view of the system illustratinga medication reservoir, a base housing, reservoir casings, a pumpassembly, and a carrying strap of-the system;

[0028]FIG. 2B is an exploded perspective view of the system illustratinga removable overlay label, a patient label, and a top housing of thebase housing for assembly to the system;

[0029]FIG. 3 is an exploded perspective view of the system illustratinga port, a plunger, the pump assembly including a motor and first andsecond pinch levers, an actuator, and the base housing including anintegral storage cavity for the carrying strap;

[0030]FIG. 4 is an exploded perspective view of the system illustratingan underside of the top housing, at least one control button, anelectronic controller and display, and a detection film having acantilever portion;

[0031]FIG. 5 is an exploded perspective view of the pump assembly;

[0032]FIG. 6A is a partially cross-sectional side view of a cam shaft,the pump assembly, and the first and second pinch levers illustratingthe pinch levers in a closed position to pinch medication inlet andoutlet tubes;

[0033]FIG. 6B is a partially cross-sectional side view of the system, asdisclosed in FIG. 6A, illustrating the first pinch lever in an openposition and the second pinch lever in a closed position to drawmedication into the pump assembly;

[0034]FIG. 6C is a partially cross-sectional side view of the system, asdisclosed in FIG. 6A, illustrating the first pinch lever in a closedposition and the second pinch lever in an open position to displacemedication from the pump assembly;

[0035]FIG. 6D is a partially cross-sectional side view of the system, asdisclosed in FIG. 6A, in combination with the plunger and the actuator,with the actuator retaining the pinch levers in the open position;

[0036]FIG. 7 is a partially cross-sectional side view of the pumpassembly;

[0037]FIG. 8 is an exploded perspective view of the port and theplunger;

[0038]FIG. 9 is an enlarged partially cross-sectional top view of theplunger disposed in the port illustrating a first, second, and thirdfluid connector;

[0039]FIG. 10 is a partially cross-sectional side view taken along line10-10 in FIG. 9 illustrating a seal disposed about the plunger beingdepressed by leak ribs extending from the port;

[0040]FIG. 11A is a partially cross-sectional top view of the systemwith the plunger in an off-position;

[0041]FIG. 11B is a partially cross-sectional view of the port and theplunger disposed in the port in the off-position from FIG. 11A;

[0042]FIG. 12A is a partially cross-sectional top view of the systemwith the plunger in a fill-position such that the system can besterilized and filled with medication;

[0043]FIG. 12B is a partially cross-sectional view of the port and theplunger disposed in the port in the fill-position from FIG. 12Aadditionally illustrating a syringe for moving the plunger into thefill-position and a fluid cap for sterilization;

[0044]FIG. 13A is a partially cross-sectional top view of the systemwith the plunger in a fluid delivery-position such that the medicationcan be delivered to the patient;

[0045]FIG. 13B is a partially cross-sectional view of the port and theplunger disposed in the port in the fluid delivery-position from FIG.13A additionally illustrating a connector from the infuision tubing set;

[0046]FIG. 14A is an enlarged perspective view of the actuator;

[0047]FIG. 14B is a perspective view of an alternative embodiment forthe actuator including a control contact disposed at a distal end of anactuation arm;

[0048]FIG. 15A is a partially cross-sectional side view of a blockagedetection system according to the subject invention when the medicationoutlet tube is in a normal condition;

[0049]FIG. 15B is a partially cross-sectional side view of the blockagedetection system of FIG. 15A when the medication outlet tube is in anexpanded condition due to a blockage;

[0050]FIG. 16A is a partially cross-sectional side view of an emptydetection system according to the subject invention when the medicationinlet tube is in a normal condition;

[0051]FIG. 16B is a partially cross-sectional side view of the emptydetection system of FIG. 16A when the medication inlet tube is in acollapsed condition due to a depletion in the supply of the medication;

[0052]FIG. 17 is a perspective view of a support platform with themedication inlet and outlet tubes which also illustrates alternativeembodiments for the blockage detection system and the empty detectionsystem where a coating is applied to the medication inlet and outlettubes;

[0053]FIG. 18A is a top perspective view of the system engaged with atesting instrument for confirming proper operation of the system afterassembly and prior to use;

[0054]FIG. 18B is a bottom perspective view of the system engaged with asecond testing instrument for confirming proper operation of the systemafter assembly and prior to use;

[0055]FIG. 19 is a perspective view of the patient using the carryingstrap as a shoulder strap to carry the system;

[0056]FIG. 20 is an enlarged top perspective view of the integralstorage cavity defined within the base housing of the system;

[0057]FIG. 21 is a perspective view of a surgeon or patient removing theremovable overlay label to reveal the patient label;

[0058]FIG. 22 is a plan view of one embodiment of the removable overlaylabel having a one version of a first set of explanatory indicia;

[0059]FIG. 23 is a plan view of a further embodiment of the removableoverlay label having another version of a first set of explanatoryindicia;

[0060]FIG. 24 is a plan view of the patient label having a second set ofexplanatory indicia;

[0061]FIG. 25 is a block diagram schematically illustrating a controlsystem for the integrated medication delivery system of the subjectinvention;

[0062]FIG. 26 is an electrical diagram illustrating portions of awatchdog circuit of the control system; and

[0063]FIG. 27 is an electrical diagram illustrating further portions ofthe watchdog circuit of the control system.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

[0064] Referring to the Figures, wherein like numerals indicate like orcorresponding parts throughout the several views, an integratedmedication delivery system 10 is generally disclosed at 10. Theintegrated medication delivery system 10, hereinafter described as thesystem 10, delivers medication to a patient 12 (refer to FIG. 19). Morespecifically, the system 10 is primarily used throughout the medicalprofession to deliver pain control medication and other medications tothe patient 12 after a surgical, or some other medical, procedure. Asdisclosed in FIG. 1B, the system 10 is used in combination with aninfusion tube set 14 to deliver the medication to the patient 12. Theinfusion tube set 14 is described below.

[0065] The system 10 of the subject invention is also suitable forcomplete sterilization by a sterilization fluid including, but notlimited to, ethylene oxide (EtO) gas. Although not ideal, certainliquids may even be used to sterilize the system 10. For descriptivepurposes only, the terminology of “medication” and of “sterilization”fluid may also be described throughout simply as a fluid.

[0066] Referring primarily to FIGS. 2A-3, the system 10 includes a basehousing 16. The base housing 16 is further defined as a bottom housing18, a middle housing 20 mounted to the bottom housing 18 and a tophousing 22, i.e., a cover. The housings 18, 20, 22 are preferablymounted together via screws 23. The system 10 also includes a medicationreservoir 24 disposed about the base housing 16. More specifically, thereservoir 24 is disposed about the middle housing 20. The reservoir 24stores the supply of medication that is to be delivered to the patient12. Preferably, the reservoir 24 is formed of a flexible, yet durableplastic material. The system 10 further includes a reservoir casing 26disposed between the bottom and top housings 18, 22. The reservoircasing 26 at least partially surrounds the reservoir 24 to protect themedication that is to be delivered to the patient 12. The preferredembodiment of the subject invention includes two reservoir casings 26that surround the reservoir 24 to protect the medication. Of course, itis to be understood that the reservoir casing 26 may be a unitarycomponent and still adequately surround the reservoir 24 to protect themedication. The reservoir casing 26 is particularly useful when thepatient 12 is carrying the system 10. Carrying of the system 10 isdescribed below.

[0067] Referring primarily to FIGS. 2A, 3, and 5-6D, a pump assembly 28is supported by the base housing 16. Specifically, the pump assembly 28is mounted to the bottom housing 18. As understood by those skilled inthe art, the pump assembly 28 is responsible for delivering themedication to the patient 12. As described below, the pump assembly 28also serves to prevent inadvertent delivery of the medication to thepatient 12.

[0068] As disclosed best in FIG. 5, the pump assembly 28 includes a pumphousing 30 having a pump inlet 32 and a pump outlet 34. The pump housing30 also has at least one detent 36. The at least one detent 36 isdescribed below. The pump inlet 32 and the pump outlet 34 alternatebetween an open and a closed state to deliver the medication to thepatient 12. Referring now to FIGS. 3, and 6A-6D, a first pinch lever 38,also referred to as a pinch valve, is disposed at the pump inlet 32 anda second pinch lever 40 or valve is disposed at the pump outlet 34. Thefirst pinch lever 38 functions to alternate the pump inlet 32 betweenthe open and the closed state, and the second pinch lever 40 functionsto alternate the pump outlet 34 between the open and the closed state.

[0069] As FIGS. 6B and 6C disclose, the first pinch lever 38 is moveablebetween an open position (FIG. 6B) and a closed position (FIG. 6C) tocontrol a flow of the medication into the pump housing 30 through thepump inlet 32, and the second pinch lever 40 is moveable between an openposition (FIG. 6C) and a closed position (FIG. 6B) to control a flow ofthe medication from the pump housing 30 through the pump outlet 34. Thepump assembly 28 further includes a motor 42 that is operatively engagedto the first and second pinch levers 38, 40 for moving these levers 38,40 into the open position such that the medication can be delivered tothe patient 12. The motor 42 includes a driving output shaft, not shownin the Figures, for driving the pump assembly 28. A power source 43 isintegrated into the system 10 to provide power to the system 10,including the motor 42. Preferably, the power source includes batteries45 and battery contacts 47.

[0070] As shown in FIG. 6A, the first pinch lever 38 is normally-biasedto maintain the pump inlet 32 in the closed state and the second pinchlever 40 is normally-biased to maintain the pump outlet 34 in the closedstate. To accomplish this, at least one biasing device 44 is included inthe pump assembly 28. Preferably, the at least one biasing device 44 isa compression spring as shown, but not numbered, throughout the Figures.However, it is to be understood that the at least one biasing device 44may be any device that is suitable for normally-biasing at least one, ifnot both, of the first and second pinch levers 38, 40 into the closedposition. The at least one biasing 44 device engages at least one of thefirst and second pinch levers 38, 40 and works in conjunction with themotor 42 to normally bias at least one of the first and second pinchlevers 38, 40 into the closed position. As such, if the motor 42 failsduring delivery of the medication, then the first and second pinchlevers 38, 40 are biased into and thereafter maintained in the closedposition to prevent the inadvertent delivery of the medication to thepatient 12. The motor 42 is able to move the first and second pinchlevers 38, 40 into the open position despite the bias of the at leastone biasing device 44.

[0071] In the preferred embodiment of the subject invention, the atleast one biasing device 44 comprises a first 46 and a second 48 biasingdevice. The first biasing device 46, preferably a compression spring,engages the first pinch lever 38, and the second biasing device 48, alsopreferably a compression spring, engages the second pinch lever 40. Asdisclosed in FIG. 6A, the first and second biasing devices 46, 48maintain the first and second pinch levers 38, 40 in the closed positionduring failure of the motor 42 thereby preventing the inadvertentdelivery of the medication to the patient 12. More specifically, theclosed first pinch lever 38 prevents the medication from being drawninto the pump assembly 28 through the pump inlet 32, and the closedsecond pinch lever 40 prevents the medication from being displaced fromthe pump assembly 28 through the pump outlet 34.

[0072] Referring primarily to FIGS. 5-6D, to effectively operate thesystem 10 and move the first and second pinch levers 38, 40 for deliveryof the medication to the patient 12, the pump assembly 28 of the subjectinvention further includes a cam shaft 50 supported on the pump housing30. The cam shaft 50 is geared to the motor 42, via a number of gears52, to operatively engage the motor 42 to the first and second pinchlevers 38, 40. The cam shaft 50 is described in greater detail below.

[0073] As disclosed best in FIGS. 5 and 7, the pump assembly 28 alsoincludes a piston 54 disposed in the pump housing 30. The motor 42 movesthe piston 54 within the pump housing 30 to draw the medication into thepump housing 30 when the first pinch lever 38 is in the open positionand the second pinch lever 40 is in the closed position (see FIG. 6B).The motor 42 also moves the piston 54 within the pump housing 30 todisplace the medication from the pump housing 30 when the first pinchlever 38 is in the closed position and the second pinch lever 40 is inthe open position (see FIG. 6C). The piston 54 includes an actuation end56 and a pumping end 58. A diaphragm seal 60 is disposed at the pumpingend 58 of the piston 54. The diaphragm seal 60 is secured at the pumpingend 58 of the piston 54 by a piston cap 62. The piston 54 also includesat least one slot 62 at the actuation end 56. The at least one detent 36of the pump housing 30, originally introduced above, engages the atleast one slot 62 at the actuation end 56 of the piston 54 to preventunwanted rotation of the piston 54 as the piston 54 is moved within thepump housing 30 by the motor 42 and the cam shaft 50.

[0074] The cam shaft 50 supports first and second outside cams 64, 66and an inside cam 68. The inside cam 68 of the cam shaft 50 is disposedbetween the first and second outside cams 64, 66. The first outside cam64 engages the first pinch lever 38 to move the first pinch lever 38between the open and closed position, and the second outside cam 66engages the second pinch lever 40 to move the second pinch lever 40between the open and closed positions. The inside cam 68 engages theactuation end 56 of the piston 54 to move the piston 54 within the pumphousing 30.

[0075] Referring to FIG. 5, the first and second outside cams 64, 66include a plurality of slits 70 along an outer circumference 72 of thecams 64, 66. These slits 70 are used during assembly and testing of thesystem 10 to confirm dimensional tuning of the cams 64, 66. Also, atleast one of the first and second outside cams 64, 66, preferably thefirst outside cam 64, includes an assembly slot 74 defined within theouter circumference 72 of the cams 64, 66. This assembly slot 74facilitates assembly of the pump assembly 28. In particular, thisassembly slot 74 facilitates mounting of the cam shaft 50, including thecams 64, 66, after the first and second pinch levers 38, 40 have alreadybeen incorporated into the system 10.

[0076] Each of the first and second pinch levers 38, 40 comprise a camfollower 76 and lever guides 78. The lever guides 78 are describedbelow. The cam followers 76 of the pinch levers 38, 40 are engaged bythe cam shaft 50 for alternating movement of the first and second pinchlevers 38, 40 between the open and closed positions such that themedication can be delivered to the patient 12. More specifically, thecam follower 76 of the first pinch lever 38 is engaged by the firstoutside cam 64 for alternating movement of the first pinch lever 38between the open and closed positions, and the cam follower 76 of thesecond pinch lever 40 is engaged by the second outside cam 66 foralternating movement of the second pinch lever 40 between the open andclosed positions. Even more specifically, each of the first and secondoutside cams 64, 66 include internal cam surfaces 80. As disclosed inFIGS. 6A-6D, the cam follower 76 of the first pinch lever 38 rideswithin the internal cam surface 80 of the first outside cam 64 foralternating movement of the first pinch lever 38, and the cam follower76 of the second pinch lever 40 rides within the internal cam surface 80of the second outside cam 66 for alternating movement of the secondpinch lever 40.

[0077] Referring primarily to FIGS. 3, and 8-10, the system 10 furtherincludes a port assembly 82 that enables various fluids, such as themedication or the sterilization fluid, to flow into, from, and withinthe system 10. The port assembly 82, hereinafter described as the port82, extends from the base housing 16. More specifically, the port 82extends from the middle housing 20. The port 82 is in fluidcommunication with the reservoir 24 and the pump assembly 28. Duringsterilization, the port 82 provides access for the sterilization fluidto flow into the reservoir 24 and the pump assembly 28. During filling,the port 82 provides access for the medication to flow into thereservoir 24 and the pump assembly 28. During delivery of the medicationto the patient 12, the port 82 provides access for the medication to bedelivered to the patient 12.

[0078] Referring particularly to FIGS. 9, and 11A-13B, the port 82includes an elongated housing 84. The elongated housing 84 includes aproximate end 86, a distal end 88, and an interior wall 90 defining afluid chamber 92 between the proximate and distal ends 86, 88. It is theproximate end 86 of the elongated housing 84 that extends from thesystem 10 to provide access for the fluid to flow both into and from thesystem 10. The port 82 further includes a first fluid connector 94, asecond fluid connector 96, and a third fluid connector 98. The firstfluid connector 94, alternatively referred to as an outlet of the port82, extends from the elongated housing 84 to allow the fluid to flowfrom the fluid chamber 92 into the pump assembly 28. The second fluidconnector 96, alternatively referred to as an inlet to the port 82,extends from the elongated housing 84 to allow the fluid to flow fromthe pump assembly 28 into the fluid chamber 92. The third fluidconnector 98, alternatively referred to as an access to the reservoir24, extends from the elongated housing 84 to allow the fluid to flowbetween the fluid chamber 92 and the reservoir 24. In the preferredembodiment of the subject invention, there are two third fluidconnectors 98, one third fluid connector 98 extending from oppositesides of the elongated housing 84.

[0079] Referring primarily to FIGS. 3, 6D, 8-10, and 11A-13B, the port82 further includes a plunger 100. The plunger 100 is disposed in thefluid chamber 92 of the port 82 and is moveable between an off-position(FIGS. 11A-11B), a fill-position (FIGS. 12A-12B), and a fluiddelivery-position (FIGS. 13A-13B). As disclosed in FIGS. 11A-11B, in theoff-position, the first, second, and third fluid connectors 94, 96, 98are isolated from the proximate end 86 of the elongated housing 84 bythe plunger 100. As a result, the flow of fluid through the port 82 isprevented. As disclosed in FIGS. 12A-12B, in the fill-position, thefirst and third fluid connectors 94, 98 are in fluid communication withthe proximate end 86 of the elongated housing 84. As a result, a fluidflow path, shown but not numbered in FIGS. 12A-12B, is provided betweenthe proximate end 86 of the elongated housing 84, the medicationreservoir 24, and the pump assembly 28 such that the fluid can be filledthrough the proximate end 86 of the housing and into the medicationreservoir 24 and the pump assembly 28. This fluid flow path is definedbetween the port 82, the reservoir 24, and the pump assembly 28 suchthat the flow of sterilization fluid through the fluid flow path iscontinuous during sterilization of the system 10. The fill-position ofthe plunger 100 is utilized when the system 10 is being sterilized withthe sterilization fluid and also when the system 10 is being filled withmedication. As disclosed in FIGS. 13A-13B, in the fluid deliveryposition, the first, second, and third fluid connectors 94, 96, 98 arein fluid communication with the proximate end 86 of the elongatedhousing 84 and with each other for supplying the pump assembly 28 andfor delivering the fluid to the patient 12.

[0080] Referring primarily to FIGS. 3, 6D, 11A, 12A, 13A, and 14A-14B,the system 10 further includes an actuator 102 disposed in the basehousing 16. The actuator 102 is moveable between a disengaged positionand an engaged position. The disengaged position of the actuator 102 isdescribed below. As disclosed in FIG. 6D, in the engaged position, theactuator 102 operatively engages the pump inlet 32 and the pump outlet34 to retain, i.e., lock, both the pump inlet 32 and the pump outlet 34in the open state during sterilization. With the pump inlet 32 and thepump outlet 34 in the open state, the sterilization fluid can penetratethroughout the entire system 10 to completely sterilize the system 10.That is, the sterilization fluid can penetrate into the reservoir 24,the pump inlet 32, the pump housing 30, and the pump outlet 34 tocompletely sterilize the system 10.

[0081] More specifically, the actuator 102 interacts with the first andsecond pinch levers 38, 40 to retain both the pump inlet 32 and the pumpoutlet 34 in the open state during sterilization. In the engagedposition, the actuator 102 moves the first pinch lever 38 away from thepump inlet 32 into the open position to retain the pump inlet 32 in theopen state, and the actuator 102 moves the second pinch lever 40 awayfrom the pump outlet 34 into the open position to retain the pump outlet34 in the open state. The actuator 102 retains both the first and secondpinch levers 38, 40 in the open position for sterilization despite thebias of the at least one biasing device 44.

[0082] On the other hand, when the actuator 102 is in the disengagedposition, as indicated by the absence of the actuator 102 from FIGS.6B-6C, the actuator 102 is operatively disengaged from the pump inlet 32and the pump outlet 34. The actuator 102 is in the disengaged positionwhen it is necessary to deliver the medication to the patient 12 suchthat the pump inlet 32 and the pump outlet 34 can alternate between theopen and closed states to deliver the medication the patient 12.Disengagement of the actuator 102 permits the pump inlet 32 and the pumpoutlet 34 to alternate between the open and closed states.

[0083] Referring particularly to FIGS. 14A-14B, the actuator 102 isdisclosed in greater detail. The actuator 102 includes a base portion104 and at least one engagement arm 106 extending from the base portion104. The at least one engagement arm 106 of the actuator 102 operativelyengages the pump assembly 28 to retain the pump inlet 32 and the pumpoutlet 34 in the open state during sterilization. In the preferredembodiment of the subject invention, the actuator 102 more specificallyincludes first and second engagement arms 108, 110, respectively,extending from the base portion 104. In the preferred embodiment, theactuator 102 also includes an actuation arm 112. The actuation arm 112extends from the base portion 104 between the first and secondengagement arms 108, 110. As shown in the Figures, the actuation arm 112extends upwardly from the base portion 104 between the first and secondengagement arms 108, 110.

[0084] During sterilization, the first engagement arm 108 of theactuator 102 engages the first pinch lever 38 to move the first pinchlever 38 away from the pump inlet 32 to retain the pump inlet 32 in theopen state. Similarly, during sterilization, the second engagement arm110 of the actuator 102 engages the second pinch lever 40 to move thesecond pinch lever 40 away from the pump outlet 34 to retain the pumpoutlet 34 in the open state.

[0085] After sterilization it is desirable to move the actuator 102 intothe disengaged position such that the pump assembly 28 can operate andthe medication can be delivered to the patient 12. As indicated by thearrow (A) in FIG. 6D, the plunger 100 moves to displace the actuator 102from the engaged position thereby moving the actuator 102 into thedisengaged position. To displace the actuator 102, the plunger 100engages the actuation and 112. The plunger 100 displaces the actuator102 from the operative engagement with the pump assembly 28 aftersterilization such that the pump inlet 32 and the pump outlet 34 canalternate between the open and the closed state to deliver themedication to the patient 12. More specifically, the plunger 100displaces the actuator 102 from the engagement with the first and secondpinch levers 38, 40 after sterilization such that medication can bedelivered to the patient 12. As such, the motor 42, which is operativelyengaged to the first and second pinch levers 38, 40, can move theselevers 38, 40 for drawing the medication into the pump housing 30through the pump inlet 32 and for displacing the medication from thepump housing 30 through the pump outlet 34.

[0086] Referring now to FIG. 14B, a control contact 114, preferably aspring-like control contact 114, may be disposed at a distal end 116 ofthe actuation arm 112 away from the base portion 104 to indicate to thesystem 10 whether the actuator 102 is in the engaged or the disengagedposition. The control contact 114 interacts with the actuation arm 112of the actuator 102 upon the movement of the actuator 102 between theengaged or the disengaged position. If the control contact 114 isincluded, it is preferred that when the actuator 102 is disengaged fromthe first and second pinch levers 38, 40, i.e., when the actuator 102 isin the disengaged position, it contacts the control contact 114 toactive an electronic controller 118. The electronic controller 118 isactivated to permit the pump assembly 28 to operate for delivering themedication to the patient 12. As indicated above, it is preferred thatthe actuation arm 112 of the actuator 102 is in contact with the controlcontact 114 when the actuator 102 is in the disengaged position. Ofcourse, it is to be understood that the opposite could be true. That is,the system 10 can be designed such that the actuation arm 112 of theactuator 102 is in contact with the control contact 114 when theactuator 102 is in the engaged position.

[0087] The system 10 further includes a medication inlet tube 120 and amedication outlet tube 122. The medication inlet tube 120 is connectedbetween the port 82 and the pump inlet 32 to provide access for thesterilization fluid to flow from the port 82 into the pump assembly 28,specifically into the pump inlet 32. The medication outlet tube 122 isconnected between the pump outlet 34 and the port 82 to provide accessfor the sterilization fluid to flow from the pump assembly 28,specifically from the pump outlet 34, into the port 82. The medicationinlet tube 120 and the first pinch lever 38 together establish the pumpinlet 32, and the medication outlet tube 122 and the second pinch lever40 together establish the pump outlet 34.

[0088] When the at least one biasing device 44 engages the first pinchlever 38 to normally-bias the first pinch lever 38 into the closedposition, the medication inlet tube 120 is pinched. As such, the pumpinlet 32 is maintained in the closed state. Similarly, when the at leastone biasing device 44 engages the second pinch lever 40 to normally-biasthe second pinch lever 40 into the closed position, the medicationoutlet tube 122 is pinched. As such, the pump outlet 34 is maintained inthe closed state. However, as disclosed in FIG. 6D, when the actuator102 is in the engaged position during sterilization, the actuator 42overcomes the bias of the at least one biasing device 44 to move thefirst pinch lever 38 away from the medication inlet tube 120 such thatthe pump inlet 32 remains in the open state, and the actuator 102overcomes the bias of the at least one biasing device 44 to move thesecond pinch lever 40 away from the medication outlet tube 122 such thatthe pump outlet 34 remains in the open state.

[0089] Referring particularly to FIGS. 3, and 8-10, the port 82 and theplunger 100 are described in greater detail. The plunger 100 includes alength L, a circumference C, and a plurality of seats 124 disposed alongthe length L and about the circumference C of the plunger 100. The seats124 extend outwardly from the circumference C of the plunger 100 to theinterior wall 90 of the elongated housing 84 of the port 82 to segregatethe fluid chamber 92 of the elongated housing 84. A fluid passage, notnumbered, is defined between each of the seats 124 and the interior wall90 of the housing. These fluid passages control the flow of fluid withinthe port 82. Although the seats 124 may suitably segregate the fluidchamber 92, it is preferred that seals 126 are disposed about each ofthe seats 126 to assist with sealing the fluid passages from oneanother. In the most preferred embodiment, which is shown in theFigures, these seals are O-rings. At least one leak rib 128 extends atleast partially along the interior wall 90 of the elongated housing 84.The at least one leak rib 128 selectively causes at least one of theseals 126 to leak when the plunger 100 is in the fill-position. Asdisclosed in the Figures, preferably there are two leak ribs 128 thatextend along the interior wall 90 of the elongated housing 84.

[0090] As shown in FIG. 11A-13B, the plunger 100 is at least partiallyhollow. As such, the plunger 100 defines an internal fluid bore 130 thatextends within the plunger 100 between the seats 124. The plunger 100further includes an access end 132 and a plunger actuation end 134. Aplunger biasing device 136, preferably a compression spring, is disposedabout the plunger actuation end 134 of the plunger 100 to bias theplunger 100 into the off-position. The internal fluid bore 130 extendsfrom the access end 132, where the fluid flows into and from theinternal fluid bore 130, toward the plunger actuation end 134. Theinternal fluid bore 130 includes a fluid duct 138 in fluid communicationwith one of the fluid passages such that the flow can flow into and fromthe internal fluid bore 130.

[0091] In the most preferred embodiment of the subject invention, theplurality of seats 124 are further defined as a first, second, third,and fourth seat 140, 142, 144, 146, respectively. The first seat 140 isdisposed toward the access end 132 of the plunger 100, the fourth seat146 is disposed toward the plunger actuation end 134 of the plunger 100,and the second and third seats 142, 144 are disposed successivelybetween the first and fourth seats 140, 146. In this embodiment, thefluid passages are further defined as a first, second, and third fluidpassage 148, 150, 152, respectively. The first fluid passage 148 isdefined between the first and second seats 140, 142 and the interiorwall 90, the second fluid passage 150 is defined between the second andthird seats 142, 144 and the interior wall 90, and the third fluidpassage 152 is defined between the third and fourth seats 144, 146 andthe interior wall 90.

[0092] A first seal 154 is disposed about the first seat 140 for sealingthe first fluid passage 148 from the access end 132 of the plunger 100,a second seal 156 is disposed about the second seat 142 for sealing thefirst and second fluid passages 148, 150 from one another, a third seal158 is disposed about the third seat 144 for sealing the second andthird fluid passages 150, 152 from one another, and a fourth seal 160 isdisposed about the fourth seat 146 for sealing the third fluid passage152 from the plunger actuation end 134 of the plunger 100. In thisembodiment, the at least one leak rib 128 extends along the interiorwall 90 of the elongated housing 84 from the proximate end 86 toward thedistal end 88 just beyond the first seal 154 such that only the firstseal 154 selectively leaks when the plunger 100 is in the fill-position.

[0093] In this most preferred embodiment, the internal fluid bore 130extends within the plunger 100 from the access end 132 to the third seat144. As such, the fluid duct 138 is in fluid communication with thesecond fluid passage 150 defined between the second and third seats 142,144 and the interior wall 90 such that the fluid can flow into and fromthe internal fluid bore 130 at the second fluid passage 150.

[0094] The off-, fill-, and fluid delivery-positions of the plunger 100are now described in the context of this most preferred embodimenthaving four seats 140, 142, 144, 146, three fluid passages 148, 150,152, and four seals 154, 156, 158, 160. Referring to FIG. 11A-11B, whenthe plunger 100 is in the off-position, the first, second, and thirdfluid connectors 94, 96, 98 are isolated from the proximate end 86 ofthe elongated housing 84 and from the access end 132 of the plunger 100by the first, second, and third seats 140, 142, 144. In thisoff-position, the first and third fluid connectors 94, 98 are alignedwith the third fluid passage 152.

[0095] Referring to FIGS. 12A-12B, when the plunger 100 is in thefill-position, the first and third fluid connectors 94, 98 are in fluidcommunication with the proximate end 86 of the elongated housing 84 andwith the access end 132 of the plunger 100 through the second fluidpassage 150 and the fluid duct 138 of the internal fluid bore 130. Inthis fill-position, the first and third fluid connectors 94, 98 arealigned with the second fluid passage 150. As such, the fluid can befilled through the access end 132 of the plunger 100, through theinternal fluid bore 130 and the fluid duct 138, and into the reservoir24 and the pump assembly 28. In the fill-position, the second fluidconnector 96 is isolated from the proximate end 86 of the elongatedhousing 84, from the access end 132 of the plunger 100, and from thefirst and third fluid connectors 94, 98 by the third and fourth seats144, 146.

[0096] Referring to FIGS. 13A-13B, when the plunger 100 is in the fluiddelivery-position, the second fluid connector 96 is in fluidcommunication with the proximate end 86 of the housing and with theaccess end 132 of the plunger 100 through said second fluid passage 150and the fluid duct 138 of the internal fluid bore 130. In the fluiddelivery-position, the medication is delivered from the pump assembly 28to the patient 12. In the fluid delivery-position, the first and thirdfluid connectors 94, 98 are isolated from the proximate end 86 of thehousing and from the access end 132 of the plunger 100 by the first andsecond seats 140, 142. However, the first and third fluid connectors 94,98 are in fluid communication with the reservoir 24 through the firstfluid passage 148 to supply the pump assembly 28 with the fluid, i.e.,with the medication. That is, in the fluid delivery-position, the firstand third fluid connectors 94, 98 are aligned with the first fluidpassage 148.

[0097] A fluid filling device, shown generally in FIG. 12B at 162,engages the proximate end 86 of the housing to automatically move theplunger 100 into the fill position for filling the reservoir 24 and thepump assembly 28. If the system 10 is being sterilized, then the fluidfilling device 162 is preferably a fluid, or sterilization, cap 164(shown detached from the system 10 in FIG. 12B) that moves the plunger100 into the fill-position to enable a sterilization fluid to penetrateinto the reservoir 24 and the pump assembly 28. The fluid cap 164, bydesign, automatically moves the plunger 100 into the fill-position.Therefore, when the system 10 is introduced into a chamber filled withthe sterilization fluid, preferably EtO gas, then the sterilizationfluid flows, or seeps, through the fluid cap 164, through the proximateend 86 of the elongated housing 84 and the access end 132 of the plunger100, through the internal fluid bore 130 and the fluid duct 138, intothe second fluid passage 150, through the third fluid connector 98 intothe reservoir 24, and through the first fluid connector 94 into the pumpassembly 28.

[0098] If the system 10 is being filled with medication, then the fluidfilling device 162 is preferably a syringe 166 that moves the plunger100 into the fill-position for filling the reservoir 24 and the pumpassembly 28. The syringe 166 (shown attached to the system 10 in FIG.12B) engages the access end 132 of the plunger 100 and, by design,automatically moves the plunger 100 into the fill-position for fillingthe reservoir 24 and the pump assembly 28 through the internal fluidbore 130. Therefore, when the system 10 is being filled, the syringe 166interacts with the proximate end 86 of the elongated housing 84 and theaccess end 132 of the plunger 100 and, as the syringe plunger isdepressed, the medication flows through the internal fluid bore 130 andthe fluid duct 138, into the second fluid passage 150, through the thirdfluid connector 98 into the reservoir 24, and through the first fluidconnector 94 into the pump assembly 28.

[0099] To deliver the medication to the patient 12, the system 10 isutilized in combination with the infusion tube set 14. Referring back toFIG. 1A, the infusion tube set 14 includes a fluid end 168 and a patientend 170. The fluid end 168 of the tube set 14, through a deliveryconnector 172, engages the proximate end 86 of the elongated housing 84and the access end 132 of the plunger 100 to automatically move theplunger 100 into the fluid delivery-position for delivering themedication to the patient 12. Therefore, as shown in FIGS. 13A-13B, whenthe pump assembly 28 is operating, the medication is drawn from thereservoir 24 through the third fluid connector 98 into the port 82 atthe first fluid passage 148, and through the first fluid connector 94into the pump inlet 32. The medication is then displaced out of the pumpassembly 28 through the pump outlet 34, through the second fluidconnector 96 into the port 82 at the second fluid passage 150, throughthe fluid duct 138 and the internal fluid bore 130 of the plunger 100,and out the access end 132 of the plunger 100 at the fluid end 168 ofthe infusion tube set 14. From there, the medication flows through theinfusion tube set 14, out the patient end 170, and to the patient 12.

[0100] Referring back to FIG. 4, the system 10 further includes theelectronic controller 118. The electronic controller 118 controls anamount of the medication that is to be delivered to the patient 12. Theelectronic controller 118 is mounted to the base housing 16,specifically to the top housing 22 of the base housing 16. Furthermore,the electronic controller 118 remains mounted to the base housing 16during sterilization such that the entire system 10, including allmechanical components, the reservoir 24, and the electronic controller118, is simultaneously sterilized. An electronic display 174 and atleast one control button 176 are mounted to the base housing 16. Theelectronic display 174 and the control button 176 interact with theelectronic controller 118 to control the amount of the medication to bedelivered to the patient 12. As with the electronic controller 118, theelectronic display 174 and the control button 176 also remain mounted tothe base housing 16 during sterilization.

[0101] The subject invention also provides a blockage detection systemwhich is generally disclosed at 178 in FIGS. 15A-15B. The blockagedetection system 178 detects a blockage in the flow of the medication tothe patient 12. The blockage detection system 178 comprises the basehousing 16, the reservoir 24, the port 82, the pump assembly 28, themedication outlet tube 122, and the electronic controller 118. Theblockage detection system 178 also includes a detection film 180 whichis described below.

[0102] In the blockage detection system 178, the electronic controller118 is mounted to the base housing 16 adjacent the outlet tube 122. Theoutlet tube 122 is mounted to the base housing 16 and, as describedabove, is connected between the pump assembly 28 and the port 82 toprovide access for the medication to flow from the pump assembly 28 intothe port 82 and to the patient 12. The outlet tube 122 has a diameterthat is contractible and expandable between a normal condition (see FIG.15A) and an expanded condition (see FIG. 15B). The diameter of theoutlet tube 122 contracts and expands in response to variations inpressure that result from the flow of the medication from the reservoir24 through the pump assembly 28 into the port 82 and to the patient 12.

[0103] As disclosed in the FIG., the outlet tube 122 is mounted to thebase housing 16 via a support platform 182. That is, the supportplatform 182 is mounted on the base housing 16 to support the outlettube 122 on the base housing 16. The support platform 182 includes atleast one tube slot 184. The at least one tube slot 184 houses thediameter of the outlet tube 122. The outlet tube 122 is mounted in thetube slot 184 such that at least a portion, not numbered, of thediameter of the outlet tube 122 is exposed to the detection film 180.

[0104] The detection film 180 is disposed between the electroniccontroller 118 and the outlet tube 122. The detection film 180 is incontact with the outlet tube 122 and remains spaced from the electroniccontroller 118 when the diameter of the outlet tube 122 is in the normalcondition, as in FIG. 15A. On the other hand, the detection film 180 isin contact with the outlet tube 122 and contacts the electroniccontroller 118 to activate the electronic controller 118 when thediameter of the outlet tube 122 is in the expanded condition, as in FIG.15B, in response to increased pressure resulting from the blockage inthe flow of the medication to the patient 12. More specifically, it ispreferred that an electronic switch 186 is embedded in the electroniccontroller 118 between the electronic controller 118 and the detectionfilm 180. The detection film 180 interacts with the electroniccontroller 118 by contacting the electronic switch 186 to activate theelectronic controller 118 when the diameter of the outlet tube 122 is inthe expanded condition.

[0105] For activating the electronic controller 118 when the diameter ofthe outlet tube 122 is in the expanded condition, it is also preferredthat the detection film 180 is conductive. Once activated by thedetection film 180, the electronic controller 118 deactivates the pumpassembly 28 to prevent delivery of the medication to the patient 12 whenthe diameter of the outlet tube 122 is in the expanded condition.Deactivation of the pump assembly 28 prevents further blockage andfurther increases in pressure. To properly ensure that the there is ablockage in the outlet tube 122, it is most preferred that theelectronic controller 118, and therefore the pump assembly 28, aredeactivated only if the diameter of the outlet tube 122 is in theexpanded condition for more than at least one cycle of the pump assembly28. This additional measure avoids false readings and the deactivationof the pump assembly 28 when the outlet tube 122 is truly not blocked.

[0106] Additionally, once activated by the detection film 180, theelectronic controller 118 may also activate an alarm 188, shownschematically in the FIG. The alarm 188, which can be audible and/orvisually displayed on the electronic display 174, would indicate theblockage that is due to the blockage in the flow of the medication tothe patient 12.

[0107] It is preferred that the detection film 180 is mounted to theelectronic controller 118. Although the detection film 180 is mounted tothe electronic controller 118, a portion, not numbered, of the detectionfilm 180 remains at least partially-spaced from the electroniccontroller 118 when the diameter of the outlet tube 122 is in the normalcondition. The detection film 180 is mounted to the electroniccontroller 118 with an adhesive layer 190. The adhesive layer 190 alsoestablishes a thickness that is necessary to space the detection film180, specifically the portion of the detection film 180, from theelectronic controller 118 when the diameter of the outlet tube 122 is inthe normal condition. The portion of the detection film 180 contacts theelectronic controller 118 to activate the electronic controller 118 whenthe diameter of the outlet tube 122 is in the expanded condition inresponse to increased pressure in the outlet tube 122.

[0108] An alternative embodiment for the blockage detection system 178is disclosed in FIG. 17. In this alternative embodiment, the detectionfilm 180 is eliminated, and a coating 192 is included. The coating 192is applied to the outlet tube 122. The coating 192 activates theelectronic controller 118 when the diameter of the outlet tube 122 is inthe expanded condition in response to increased pressure resulting fromthe blockage in the flow of the medication to the patient 12. As withthe detection film 180, the coating 192 is preferably conductive. If thecoating 192 is present, it is most preferred that the coating 192 isformed of conductive carbon. However, other coatings may be used thatimpart conductive properties to the coating 192.

[0109] For the most part, the other characteristics of this alternativeembodiment for the blockage detection system 178 are identical to thecharacteristics that were described above in the preferred embodimentfor the blockage detection system 178. Notably, the outlet tube 122 ismounted in the tube slot 184 in this alternative embodiment such that atleast a portion of the coating 192 is exposed beyond the tube slot 184.

[0110] The subject invention also provides an empty detection systemwhich is generally disclosed at 194 in FIGS. 16A-16B. The emptydetection system 194 determines when a supply of the medication has beendepleted. The empty detection system 194 comprises the base housing 16,the reservoir 24 for storing the supply of the medication to bedelivered to the patient 12, the port 82, the pump assembly 28, themedication inlet tube 120, and the electronic controller 118. As withthe blockage detection system 178, the preferred embodiment of the emptydetection system 194 also includes a detection film, also numbered 180,which is described below.

[0111] In the empty detection system 194, the electronic controller 118is mounted to the base housing 16 adjacent the inlet tube 120. The inlettube 120 is mounted to the base housing 16 and, as described above, isconnected between the reservoir 24 and the pump assembly 28 to provideaccess for the medication to flow from the reservoir 24 into the pumpassembly 28 and to the patient 12. The inlet tube 120 has a diameterthat is contractible and expandable between a normal condition (see FIG.16A) and a collapsed condition (see FIG. 16B). The inlet tube 120contracts into the collapsed condition and expands from the collapsedcondition into the normal condition. The diameter of the inlet tube 120contracts and expands in response to variations in pressure that resultfrom a lack of the flow of the medication from the reservoir 24 throughthe pump assembly 28 and to the patient 12.

[0112] As disclosed in the FIG., the inlet tube 120 is mounted to thebase housing 16 via the support platform 182. That is, the supportplatform 182 is mounted on the base housing 16 to support the inlet tube120 on the base housing 16. The support platform 182 includes the atleast one tube slot 184. The at least one tube slot 184 houses thediameter of the inlet tube 120. The inlet tube 120 is mounted in thetube slot 184 such that at least a portion of the diameter of the inlettube 120 is exposed to the detection film 180.

[0113] The detection film 180 is disposed between the electroniccontroller 118 and the inlet tube 120. As shown in FIG. 16A, thedetection film 180 is in contact with the inlet tube 120 and contactsthe electronic controller 118 to activate the electronic controller 118when the diameter of the inlet tube 120 is in the normal condition. Onthe other hand, as shown in FIG. 16B, the detection film 180 becomesspaced from the electronic controller 118 to deactivate the electroniccontroller 118 when the diameter of the inlet tube 120 is in thecollapsed condition in response to the lack of flow of the medicationthat results from the supply of the medication being depleted.

[0114] It is preferred that an electronic switch 186 is embedded in theelectronic controller 118 between the electronic controller 118 and thedetection film 180. The detection film 180 contacts the electronicswitch 186 to activate the electronic controller 118 when the diameterof the inlet tube 120 is in the normal condition, and the detection film180 becomes spaced from the electronic switch 186 to deactivate theelectronic controller 118 when the diameter of the inlet tube 120 is inthe collapsed condition.

[0115] As best disclosed in FIG. 4, the detection film 180 morespecifically includes a film base portion 196 and a cantilever portion198. The film base portion 196 of the detection film 180 is mounted tothe electronic controller 118 away from the electronic switch 186, andthe cantilever portion 198 of the detection film 180 is adjacent theelectronic switch 186. More specifically, the cantilever portion 198extends from the film base portion 104 to contact the electronic switch186 when the diameter of the inlet tube 120 is in the normal condition.It is the cantilever portion 198 of the detection film 180 that becomesspaced from the electronic controller 118 to deactivate the electroniccontroller 118 when the diameter of the inlet tube 120 is in thecollapsed condition. For activating the electronic controller 118 whenthe diameter of the inlet tube 120 is in the normal condition, it isalso preferred that the detection film 180, specifically the cantileverportion 198 of the detection film 180, is conductive. Preferably, thedetection film 180 is mounted to the electronic controller 118 with anadhesive layer 190. Of course, it is the film base portion 196 of thedetection film 180 that is directly mounted to the electronic controller118. The cantilever portion 198 of the detection film 180 is notdirectly mounted, or otherwise adhered, to the electronic controller 118such that this portion of the detection film 180 can become spaced fromthe electronic controller 118 when the diameter of the inlet tube 120 isin the collapsed condition.

[0116] Once the detection film 180 becomes spaced from the electroniccontroller 118, i.e., when the diameter of the inlet tube 120 is in thecollapsed condition, the portion of the electronic controller 118 thatinteracts with the pump assembly 28 is deactivated such that the pumpassembly 28 is deactivated. Deactivation of the pump assembly 28 afterit has been determined that the supply of the medication has beendepleted prevents a build up of air in the system. To properly ensurethat the supply of the medication has been depleted, it is mostpreferred that the electronic controller 118, and therefore the pumpassembly 28, are deactivated only if the diameter of the inlet tube 120is in the collapsed condition for more than at least one cycle of thepump assembly 28. This additional measure avoids false readings and thedeactivation of the pump assembly 28 when the supply of the medicationis truly not depleted.

[0117] Additionally, deactivation of the portion of the electroniccontroller 118 that interacts with the pump assembly 28 may also causethe electronic controller 118 to activate the alarm 188. The alarm 188,which can be audible and/or visually displayed on the electronic display174, would indicate the lack of flow of the medication when the diameterof the inlet tube 120 is in the collapsed condition due to the lack offlow of the medication to the patient 12.

[0118] An alternative embodiment for the empty detection system 194 isdisclosed in FIG. 17. In this alternative embodiment, the detection film180 is eliminated, and the coating 192 is included. The coating 192 isapplied to the inlet tube 120. The coating 192 contacts the electroniccontroller 118 to activate the electronic controller 118 when thediameter of the inlet tube 120 is in the normal condition. On the otherhand, the coating 192 becomes spaced from the electronic controller 118to deactivate the electronic controller 118 when the diameter of theinlet tube 120 is in the collapsed condition in response to the lack offlow of the medication resulting from the supply of the medication beingdepleted. As with the detection film 180, the coating 192 is preferablyconductive. If the coating 192 is present, it is most preferred that thecoating 192 is formed of conductive carbon. However, other coatings maybe used that impart conductive properties to the coating 192.

[0119] For the most part, the other characteristics of this alternativeembodiment for the empty detection system 194 are identical to thecharacteristics that were described above in the preferred embodimentfor the empty detection system 194. Notably, the inlet tube 120 ismounted in the tube slot 184 in this alternative embodiment such that atleast a portion of the coating 192 is exposed beyond the tube slot 184.

[0120] Referring now to FIG. 1B, 6A-6D, and 18A-18B, the system 10 ofthe subject invention can be tested using a testing instrument 200 afterassembly of the system 10. The system 10 is tested after assembly andprior to shipment and use by the surgeons, patients, and the like toconfirm various operations of the system 10. In the preferredembodiment, to test the system 10, the system 10 is mounted onto thetesting instrument 200. One operation of the system 10 that is confirmedafter assembly of the system 10 is the operation of the pump assembly28.

[0121] To confirm these operations, the system 10 includes at least onetesting access port 202. The at least one testing access port 202 isdefined within the base housing 16 and is aligned with at least one ofthe pump inlet 32, the pump outlet 34, and the actuator 102. Preferably,the at least one testing access port 202 is aligned with all three ofthe pump inlet 32, the pump outlet 34, and the actuator 102. The atleast one testing access port 202 provides access for the testinginstrument 200 to move the actuator 102 between the disengaged positionand the engaged position. If the at least one testing access port 202 isaligned with the pump inlet 32 and the pump outlet 34 then it is alignedwith the first and second pinch levers 38, 40, respectively. Also, asfor the alignment with the actuator 102, the at least one testing accessport 202 is more specifically aligned with the at least one engagementarm 106 of the actuator 102. This provides access for the testinginstrument 200 to move the actuator 102 between the disengaged positionand the engaged position.

[0122] The system 10 is preferably assembled with the actuator 102 inthe engaged position such that the first and second pinch levers 38, 40are in the open position and the resiliency and life of the medicationinlet and outlet tubes 120, 122 is not compromised. Because the at leastone testing access port 202 provides access for the testing instrument200 to move the actuator 102 between the disengaged position and theengaged position, the testing instrument 200 can be inserted into the atleast one testing access port 202 to disengage the actuator 102, i.e.,to move the actuator 102 into the disengaged position. As such, the pumpinlet 32 and the pump outlet 34 can alternate between the open andclosed states after assembly and during testing of the system 10.

[0123] The at least one testing access port also provides access for thetesting instrument 200 such that the pump inlet 32 and the pump outlet34 can be retained in the open state after the system 10 has been testedto prepare the system 10 for sterilization. That is, after the system 10has been tested, the actuator 102 is moved from the disengaged positionback into the engaged position to prepare the system 10 forsterilization. In the engaged position, the first and second pinchlevers 38, 40 are retained in the open state.

[0124] In the preferred embodiment, the at least one testing access port202 is further defined as first, second, and third testing access ports204, 206, 208, respectively. The first testing access port 204 isaligned with the pump inlet 32, the second testing access port 206 isaligned with the pump outlet 34, and the third testing access port 208is aligned with the actuator 102 for providing access to the testinginstrument 200 to move the actuator 102 into the engaged position. Morespecifically, the first testing access port 204 is aligned with thefirst pinch lever 38 such that the first pinch lever 38 is engaged bythe testing instrument 200. Once inside the first testing access port204, the testing instrument 200 forces the first pinch lever 38 awayfrom the pump inlet 32 and forces the pump inlet 32 into the open state.Similarly, the second testing access port 206 is aligned with the secondpinch lever 40 such that the second pinch lever 40 is engaged by thetesting instrument 200. Once inside the second testing access port 206,the testing instrument 200 forces the second pinch lever 40 away fromthe pump outlet 34 and forces the pump outlet 34 into the open state.The first and second pinch levers 38, 40 include the lever guides 78opposite the cam follower 76 of each pinch lever 38, 40. To move thefirst and second pinch levers 38, 40, the testing instrument 200 engagesthe lever guides 78 upon insertion into the first and second testingaccess ports 204, 206. After the testing instrument 200 forces the firstand second pinch levers 38, 40 away from the pump inlet 32 and the pumpoutlet 34, respectively, the testing instrument 200 is introduced intothe third testing access port 208 and the actuator 102 is moved into theengaged position to engage and retain the pinch levers 38, 40 in theopen position such that the system 10 is now prepared for sterilization.It is to be understood by those skilled in the art that the testinginstrument 200 includes male prongs, generally indicated at 210, thatare introduced into the testing access ports 204, 206, 208.

[0125] The system 10 further includes at least one controller accessport 212 defined within the base housing 16. In the preferredembodiment, the at least one controller access port 212 is definedwithin the top housing 22 or cover. The at least one controller accessport 212 is aligned with the electronic controller 118 to provide accessfor a second testing instrument 214. It is to be understood that thesecond testing instrument 214 and the testing instrument 200 may be aunitary component, as disclosed in the FIG. The second testinginstrument 214 causes the electronic controller 118 to activate themotor 42 such that the motor 42 is powered to alternate the pump inlet32 and the pump outlet 34 between the open and closed states afterassembly and during testing of the system 10. The second testinginstrument 214 also preferably includes male prongs 210 that areintroduced into the controller access ports 212.

[0126] Referring primarily to FIGS. 2A-3, and 19-20, the system 10 ofthe subject invention is also suitable to be carried by the patient 12.To facilitate carrying of the system 10 so the patient 12 can remainambulatory, a carrying strap 216 is mounted within the base housing 16for the carrying of the system 10 by the patient 12. An integral storagecavity 218 is defined within the base housing 16. The carrying strap 216is at least partially disposed in the integral storage cavity 218. Thecarrying strap 216 at least partially extends from the integral storagecavity 218 to interact with the patient 12 for carrying the system 10.

[0127] The system 10 further includes a plurality of cavity walls. Thecavity walls extend from the bottom housing 18 to define the integralstorage cavity 218 between the bottom 18 and top 22 housings. Referringparticularly to FIG. 20, the cavity walls are further defined as a frontwall 220, a rear wall 222, and first and second side walls 224 extendingbetween the front and rear walls 220, 222 to support the front and rearwalls 220, 222 and to define the integral storage cavity 218. At leastone strap slot 226 is defined within the front wall 220 such that atleast a portion, not numbered, of the carrying strap 216 extends fromthe integral storage cavity 218 and through the strap slot 226. Thepatient 12 can then access the portion of the carrying strap 216 whendesired.

[0128] In interacting with the carrying strap 216, the patient 12 simplymanipulates, or grabs, the portion of the carrying strap 216 to pull alength of the carrying strap 216 from the integral storage cavity 218.This length is then looped about the head of the patient 12 asspecifically disclosed in FIG. 19. In the preferred embodiment, thecarrying strap 216 is retractable into the integral storage cavity 218after the length has been pulled from the integral storage cavity 218 bythe patient 12. The system 10 further includes a clip 228 that connectsopposing ends of the carrying strap 216 such that the carrying strap 216is adjustable to fit patients 12 of all sizes. In the most preferredembodiment of the subject invention, which is disclosed in FIG. 19, thecarrying strap 216 is further defined as a shoulder strap. The shoulderstrap suspends from a shoulder of the patient 12 for carrying the system10.

[0129] Also, as particularly disclosed in FIG. 1B, the system 10 mayalso further include a system mounting clip 230 that extends from anexterior facing 232 of the base housing 16. The system mounting clip 230can be mounted to a belt 234 of the patient 12. Of course, it is to beunderstood that the system mounting clip 230 is not to be limited to aclip for a belt 234. Instead, the system mounting clip 230 may bemounted to a shirt, a pocket, and the like.

[0130] Referring to FIGS. 2B, and 21-24, the subject invention furtherprovides a method of controlling the system 10. This method is designedto be convenient for both the surgeon, or other medical professional,and the patient 12. A patient label 236, having a second set ofexplanatory indicia, i.e., instructions, is mounted, preferably adhered,to the system 10. A removable overlay label 238, having a first set ofexplanatory indicia, i.e., instructions, is mounted, preferably adhered,to the patient label 236 to at least partially cover the patient label236.

[0131] The method includes the steps of selecting the amount of themedication in accordance with the first set of explanatory indicia onthe removable overlay label 238. The medical professional selects theamount of the medication. As such, the first set of explanatory indiciais intended to be readily understood by the medical professional.Typically, the amount of the medication is selected by selecting theflow rate for the medication. Other parameters including, but notlimited to, the bolus amount, the drug or medication concentration, andlike, can also be selected.

[0132] Throughout the step of selecting, the medical professional and/orpatient 12 interfaces with the electronic display 174 to view his or herselections. More specifically, the electronic display 174 presents areadable output for the medical professional and the patient 12. Thereadable output displayed on the electronic display 174 is correlatedwith the removable overlay label 238 and the patient label 236. That is,the readable output is correlated to the first and second sets ofinstructions. A first readable output is presented on the electronicdisplay 174. The first readable output is linked with the first set ofexplanatory indicia when the removable overlay label 238 is displayed.Similarly, a second readable output is presented on the electronicdisplay 174. The second readable output is linked with the second set ofexplanatory indicia after the system 10 has been locked. Locking thesystem 10 is described immediately below.

[0133] After the amount of the medication has been selected, the system10 is locked such that selected amount of the medication to be deliveredto the patient 12 is unable to be modified. After the medicalprofessional is satisfied with his or her selection, the medicalprofessional depresses the “LOCK” portion of the first set ofexplanatory indicia on the removable overlay label 238 to lock thesystem 10.

[0134] Once the system 10 is locked, either the medical professional orthe patient 12 can remove the removable overlay label 238 to reveal thepatient label 236 (as shown in FIG. 21). To accomplish this, the user,either the medical professional or the patient 12, simply pulls theremovable overlay label 238 off the patient label 236. This reveals thecontrol button 176 that was originally masked under the removableoverlay label 238. The system 10 is then operated in accordance with asecond set of explanatory indicia on the patient label 236. The secondset of explanatory indicia is intended to be readily understood by thepatient 12. Once the system 10 is locked, the system 10 is designed tobe convenient for use by the patient 12.

[0135] Upon locking the system 10, a functionality of the control button176 is modified. As such, the functionality of the control button 176 isdifferent when the removable overlay label 238 is displayed on thesystem 10 as compared to when the patient label 236 is displayed on thesystem 10. In other words, the functionality of the control button 176is different when the medical professional interacts with the system 10via the removable overlay label 238 as compared to when the patient 12interacts with the system 10 via the patient label 236. When theremovable overlay label 238 is displayed on the system 10, the controlbutton 176 is at least trifunctional. On the other hand, after thesystem 10 has been locked and the patient label 236 is displayed on thesystem 10, the functionality of the control button 176 is converted frombeing at least tri-functional to being bi-functional.

[0136] In operating the system 10, the system 10 may be deactivated, ifnecessary, to stop delivery of the medication to the patient 12. Todeactivate the system 10, the patient 12 depresses the “ON/OFF” portionof the, now bi-functional, control button 176 in response to the secondset of explanatory indicia on the patient label 236. If the system 10 isdeactivated, then the patient 12 may also use the control button 176 toactivate the system 10 to re-start delivery of the medication to thepatient 12. To accomplish this, the patient 12 depresses the “ON/OFF”portion of the control button 176 again.

[0137] Alternatively, in operating the system 10, the patient 12 mayrequest an additional amount of the medication relative to the selectedamount of the medication, and provided the Bolus amount will not beviolated, the patient 12 will receive an additional amount of themedication. To request an additional amount of the medication relativeto the selected amount, the patient 12 actuates the control button 176.

[0138] With specific reference to FIG. 25, a control system 240 for thesystem 10, according to an embodiment of the present invention is shown.The control system 240 includes the electronic controller 118 and amotor control circuit 242. The electronic controller 118 controlsoperation of the system 10 as described above.

[0139] In one embodiment, the electronic controller 118 includes amicroprocessor 244. One suitable microprocessor 244 is available fromPhilips Semiconductor of Sunnyvale, Calif. as model no. 87LPC764. Theelectronic controller 118 is programmed to control operation of themotor control circuit 242 with a computer software program. In general,the electronic controller 118 generates control signals in accordancewith the computer software program and delivers the control signals tothe motor control circuit 242.

[0140] The motor control circuit 242 includes a first switch 246. Thefirst switch 246 has an open state and a closed state.

[0141] The control system 240 also includes a watchdog circuit 248coupled to the electronic controller 118. The watchdog circuit 248includes a monitor circuit 250 and a second switch 252. The secondswitch 252 has an open state and a closed state and is coupled to thefirst switch 246. The monitor circuit 250 is adapted to detect anabnormal condition of the control system 240 and to turn the secondswitch 252 off if the abnormal condition is detected. Examples of anabnormal condition include, but are not limited to, too many revolutionsof the motor 42, failure of the electronic controller 118, failure ofthe first switch 246, or failure of a motor sensor 254 (see below).

[0142] The motor control circuit 242 is adapted to receive controlsignals from the electronic controller 118 and to responsively supplypower to the motor 42 by placing the first switch 246 in the closedstate. Power is supplied to the motor 42 if the first and secondswitches 246, 252 are in the closed state.

[0143] With reference to FIGS. 26 and 27, in one embodiment the firstand second switches 246, 252 are field effect transistors (FETs) 256,258.

[0144] In one embodiment, the control system 240 includes the controlbuttons 176. A user such as the surgeon or the patient 12 is able toprogram the control system 240 to deliver medication at the desired flowrate. Based on the desired flow rate, the electronic controller 118controls energization of the motor 42 to deliver the medication.

[0145] In one embodiment, each revolution of the motor 42 delivers a setamount of the medication during a known period of time. In order to meetthe desired flow rate, the electronic controller 118 calculates a periodof time between revolutions of the motor 42.

[0146] In one embodiment, the motor control circuit 242 includes themotor sensor 254 (see FIG. 4). The motor sensor 254 is coupled to themotor 42 and is adapted to detect a revolution of the motor 42 and toresponsively generate a motor revolution signal in response tocompletion of the motor 42 revolution. In one embodiment, the motorsensor 254 is a opto-coupler sensor which is adapted to detect thepresence of an indicating flag 260 (see FIG. 5) connected to the motor42. The indicating flag 260 extends from one of the first and secondoutside cams 64, 66 to assist in monitoring the amount of the medicationthat has been delivered to the patient 12. The sensor 254 isoptically-coupled with the indicating flag 260 to count revolutions ofthe indicating flag 260. One suitable sensor 254 is available from Omronof Schaumburg, Ill., as model no. EE-SX1109.

[0147] In one embodiment, the electronic controller 118 is adapted toreset the watchdog circuit 248 prior to sending control signals to themotor 42 control circuit to energize the motor 42. The watchdog circuit248 is adapted to place the second switch 252 in the opened state if twomotor revolution signals are received without the watchdog circuit 248being reset.

[0148] In other words, the electronic controller 118 must reset thewatchdog circuit 248 prior to or between each revolution of the motor42. Thus, if a failure of the electronic controller 118 or themicroprocessor 244 erroneously causes a control signal to be deliveredto the motor control circuit 242 to continuously place the first switch246 in the closed state, and thus, to erroneously energize the motor 42,the second switch 252 will be placed in the opened state. With thesecond switch 252 in the opened state, power will not be delivered tothe motor 42.

[0149] Additionally, if a failure of the first switch 246 leaves thefirst switch 246 in the closed state, successive motor revolutionsignals will be received by the watchdog circuit 248 without thewatchdog circuit 248 being reset and the watchdog circuit 248 will placethe second switch 252 in the opened state, thus preventing power frombeing supplied to the motor 42.

[0150] In one embodiment, the electronic controller 118 is adapted totrack the time after a motor control signal has been sent and to enter adisabled state if the time between the sent control signal and receivedmotor revolution signal exceeds a predetermined threshold.

[0151] With specific reference to FIG. 26, in one embodiment the monitorcircuit 248 includes first and second flip-flops 262, 264. The firstflip-flop 262 is coupled to the electronic controller 118 and the secondflip-flop 264. The second flip-flop 264 is coupled to the second FET258.

[0152] In the illustrated embodiment, the first and second flip-flops262, 264 are JK flip-flops. The inverse output ({overscore (Q)}) of thesecond flip-flop 264 is connected to the gate of the second FET 258. Theclock input (CLK) of the second flip-flop 264 is coupled to the output(Q) of the first flip-flop 262. Power is supplied by the microprocessor244 to the first and second flip-flops 262, 264 to the J and K inputs ofthe first flop 262 and to the J input of the second flip-flop 264. Thedrain of the second FET 258 is coupled to the first FET 256 and thesource of the second FET 258 is connected to electrical ground.

[0153] The watchdog circuit 248 is reset by shutting off and restoringpower to the first and second flip-flops 262, 264, to the J and K inputsof the first flop 262, and to the J input of the second flip-flop 264.In one embodiment, the electronic controller 118 shuts off power to thefirst and second flip-flops 262, 264 after each revolution of the motor42 and supplies power prior to turning on the first switch 246 to beginthe next cycle. This has two effects: conserving power and resetting thefirst and second flip-flops 262, 264.

[0154] The clock input (CLK) of the first flip-flop 262 is connected tothe output of the motor sensor 254. The clock input (CLK) of the firstflip-flop 262 is also connected to the microprocessor 244 via a thirdFET 266. The third FET 266 provides isolation between the microprocessor244 and the motor sensor 254 and the monitor circuit 248. This isolationprevents a shorted pin on the electronic controller 118 from preventingrevolution pulses from reaching the flip-flops 262, 264.

[0155] The inverse clear input ({overscore (CLR)}) of the first andsecond flip-flops 262, 264 are coupled to the microprocessor 244 via abuffer circuit 268. In the illustrated embodiment, the buffer circuit268 includes a first buffer 270, a first resistor 272 and a capacitor274. The electronic controller 118 may continuous supply power to themotor 42 by turning on the first switch 246 and continuously resettingthe first and second flip-flops 262, 264 through the inverse clearinputs without turning off power to the flip-flops 262, 264.

[0156] In one embodiment, the flip-flops 262, 264 are triggered by logiclevel high (“HIGH”) to logic level low (“LOW”) transitions. The buffercircuit 268 prevents erroneous signal transitions when the input to thebuffer circuit 268 is held HIGH by the microprocessor 244.

[0157] With specific reference to FIG. 27, the motor control circuit 242includes the first FET 256 and the opto-coupler sensor 276. A flashbackdiode 278 is coupled across first and second motor junctions 280A, 280B.The opto-coupler sensor 276 is coupled to the second motor junction280B. The transmitting diode of the opto coupler sensor 276 is coupledto power (V+) and ground through switch 256. In this arrangement thesensor 276 is only powered during the time the motor 42 is running thusconserving battery life. An output of the opto-coupler sensor 276 iscoupled to the third transistor 266 via a second buffer 282.

[0158] The gate of the first FET 256 is coupled to the microprocessor244. The drain of the first FET 256 is coupled to the motor 42 and thesource of the first FET 256 is connected to the drain of the second FET258.

[0159] As described above, the electronic controller 118 is adapted tosupply medication by energizing the motor 42. A desired flow rate isachieved by energizing the motor 42 and waiting between revolutions ofthe motor 42 for a calculated period of time. The motor 42 is energizedby turning on the first FET 256. In the illustrated embodiment, thefirst FET 256 is turned on by the microprocessor 244 by changing thestate of the gate of the first FET 256 from LOW to HIGH. If the secondFET 258 is also on, then power flows through the motor 42 and the firstand second FETs 256, 258. When the motor 42 has made one (1) completerevolution, then the output of the motor sensor 254 transitions fromHIGH to LOW. In the illustrated embodiment, this transition is the motorrevolution signal. The motor revolution signal is also transmitted tothe microprocessor 244 via the third FET 266. After receiving the motorrevolution signal the microprocessor 244 turns off the first FET 256 bychanging the state of the gate of the first FET 256 from HIGH to LOW.

[0160] During normal operation, the microprocessor 244 then turns offpower to the first and second flip-flops 262, 264. As described above,based on the desired flow rate and the known quantity of medicationdelivered per revolution of the motor 42, the microprocessor 244calculates a wait period between motor revolutions. After the waitperiod (or right before the wait period ends), the microprocessor 244restores power to the first and second flip-flops 262, 264. As discussedabove, this resets the first and second flip-flops 262, 264. Then themicroprocessor 244 may again turn on the first FET 256 to energize themotor 42.

[0161] If a failure condition of the control system 240 exists, such asa microprocessor 244 failure or other failure, and the watchdog circuit248 is not reset, then watchdog circuit 248 turns off the second FET258, thereby preventing power from being supplied to the motor 42.

[0162] For example, if the microprocessor 244 fails while the first FET256 is on, then the motor 42 will continue to be energized. The motorsensor 254 will generate motor revolution signals each time a motorrevolution is completed. However, the microprocessor 244 does not or isunable to reset the watchdog circuit 248. Two successive motorrevolution signals received on the CLK input of the first flip-flop 262without the watchdog circuit 248 being reset will flip the inverseoutput of the second flip-flop 264 (from HIGH to LOW) and thus turn offthe second FET 258.

[0163] Likewise, a failure of the first transistor 256 in the closedstate will continuously energize the motor 42. If the microprocessor 244does not reset the watchdog circuit 248, then successive motorrevolution signals received on the CLK input of the first flip-flop 262will flip the inverse output of the second flip-flop 264 and thus turnoff the second FET 258.

[0164] With the second FET 258 in the off state, power will not bedelivered to the motor 42.

[0165] Returning to FIG. 25, the control system 240 further includes akey 284 which is connected to the electronic controller 118 only duringinitialization. In one embodiment, the key 284 is part of the testinginstrument 200 which is also used to test the control system 240 afterit has been assembled and the batteries 45 are installed. Upon initialpower-up, the control system 240 will only initialize if the key 284 ispresent. If the key 284 is not present, then the control system 240enters a disabled mode and medication cannot be delivered.

[0166] In one embodiment, upon initial power-up the control system 240sends a signal to the key 284. If present, the key 284 delivers a returnsignal to the control system 240 indicating its presence. The use of thekey 284 ensures that the system 10 cannot be improperly reset byremoving and then re-inserting the batteries 45 or other power supply43. If this occurs and the key 284 is not present, the system 10 willnot work.

[0167] The control system 240 includes a crystal 285 coupled to themicroprocessor 244. The crystal 285 controls the frequency at which themicroprocessor 244 operates in a conventional manner. However, if thecrystal 285 is operating improperly, the microprocessor 244 could beginto operate at either a higher frequency or a lower frequency thanintended. The microprocessor 244 also includes an internal oscillator286. In one embodiment, the control system 240 is adapted to compare afrequency of the crystal 285 with a frequency associated with theinternal oscillator 286. The electronic controller 118 adapted tocompare a difference between the first and second frequencies and entera disabled state if the difference is greater than a predeterminedthreshold. Thus, if the crystal 285 experiences a failure, the controlsystem 10 will be disabled.

[0168] The invention has been described in an illustrative manner, andit is to be understood that the terminology which has been used isintended to be in the nature of words of description rather than oflimitation.

[0169] Obviously, many modifications and variations of the presentinvention are possible in light of the above teachings. It is,therefore, to be understood that reference numerals are merely forconvenience and are not to be in any way limiting, the invention may bepracticed otherwise than as specifically described.

What is claimed is:
 1. An integrated medication delivery system fordelivering medication to a patient wherein said system is suitable forcomplete sterilization by a sterilization fluid, said system comprising:a base housing; a medication reservoir disposed about said base housingfor storing the medication to be delivered to the patient; a pumpassembly supported by said base housing for delivering the medication tothe patient, said pump assembly comprising a pump housing having a pumpinlet and a pump outlet, wherein said pump inlet and said pump outletalternate between an open and a closed state to deliver the medicationto the patient; a port extending from said base housing, said port beingin fluid communication with said medication reservoir and said pumpassembly during sterilization to provide access for the sterilizationfluid to flow into said medication reservoir and said pump assembly; andan actuator disposed in said base housing and operatively engaging saidpump inlet and said pump outlet to retain both said pump inlet and saidpump outlet in said open state during sterilization such that thesterilization fluid can penetrate into said medication reservoir, saidpump inlet, said pump housing, and said pump outlet to completelysterilize said system.
 2. A system as set forth in claim 1 furthercomprising a first pinch lever disposed at said pump inlet that isnormally-biased to maintain said pump inlet in said closed state, and asecond pinch lever disposed at said pump outlet that is normally-biasedto maintain said pump outlet in said closed state.
 3. A system as setforth in claim 2 wherein said actuator moves said first pinch lever awayfrom said pump inlet to retain said pump inlet in said open state duringsterilization and moves said second pinch lever away from said pumpoutlet to retain said pump outlet in said open state duringsterilization.
 4. A system as set forth in claim 1 wherein said actuatoris operatively disengaged from said pump inlet and said pump outletduring delivery of the medication to the patient such that said pumpinlet and said pump outlet can alternate between said open and closedstates to deliver the medication the patient.
 5. A system as set forthin claim 1 further comprising an electronic controller mounted to saidbase housing for controlling an amount of the medication to be deliveredto the patient, wherein said electronic controller remains mounted tosaid base housing during sterilization.
 6. A system as set forth inclaim 5 further comprising an electronic display and at least onecontrol button mounted to said base housing for interacting with saidelectronic controller to control the amount of the medication to bedelivered to the patient, wherein said electronic display and saidcontrol button remain mounted to said base housing during sterilization.7. A system as set forth in claim 1 further comprising a fluid flow pathfor the sterilization fluid defined between said port, said medicationreservoir, and said pump assembly such that the flow of thesterilization fluid through said fluid flow path is continuous duringsterilization of said system.
 8. A system as set forth in claim 2further comprising; a medication inlet tube connected between said portand said pump inlet to provide access for the sterilization fluid toflow from said port into said pump assembly; and a medication outlettube connected between said pump outlet and said port to provide accessfor the sterilization fluid to flow from said pump assembly into saidport.
 9. A system as set forth in claim 8 wherein said first pinch leveris normally-biased to pinch said medication inlet tube such that saidpump inlet is maintained in said closed state, and said second pinchlever is normally-biased to pinch said medication outlet tube such thatsaid pump outlet is maintained in said closed state.
 10. A system as setforth in claim 9 wherein said actuator moves said first pinch lever awayfrom said medication inlet tube such that said pump inlet remains insaid open state during sterilization and moves said second pinch leveraway from said medication outlet tube such that said pump outlet remainsin said open stated during sterilization.
 11. A system as set forth inclaim 2 wherein said actuator comprises a base portion and first andsecond engagement arms extending from said base portion, said firstengagement arm of said actuator engaging said first pinch lever to movesaid first pinch lever away from said pump inlet to retain said pumpinlet in said open state during sterilization, and said secondengagement arm of said actuator engaging said second pinch lever to movesaid second pinch lever away from said pump outlet to retain said pumpoutlet in said open state during sterilization.
 12. A system as setforth in claim 11 further comprising a plunger disposed within said portfor displacing said actuator from said engagement with said first andsecond pinch levers after sterilization such that said pump inlet andsaid pump outlet can alternate between said open and said closed stateto deliver the medication to the patient.
 13. A system as set forth inclaim 12 wherein said actuator further comprises an actuation armextending from said base portion between said first and secondengagement arms, said actuation arm being engaged by said plunger todisplace said actuator from said engagement with said first and secondpinch levers after sterilization.
 14. A system as set forth in claim 13further comprising an electronic controller mounted to said base housingfor controlling an amount of the medication to be delivered to thepatient, wherein said electronic controller remains mounted to said basehousing during sterilization.
 15. A system as set forth in claim 14further comprising a control contact disposed at a distal end of saidactuation arm away from said base portion, said control contactactivating said electronic controller when said actuator is disengagedfrom said first and second pinch levers thereby permitting said pumpassembly to operate for delivering the medication to the patient.
 16. Asystem as set forth in claim 1 further comprising a plunger disposedwithin said port for displacing said actuator from said operativeengagement with said pump inlet and said pump outlet after sterilizationsuch that said pump inlet and said pump outlet can alternate betweensaid open and said closed state to deliver the medication the patient.17. A system as set forth in claim 1 wherein said actuator comprises abase portion and at least one engagement arm extending from said baseportion, said at least one engagement arm of said actuator operativelyengaging said pump assembly to retain said pump inlet and said pumpoutlet in said open state during sterilization.
 18. A system as setforth in claim 17 further comprising a plunger disposed within said portfor displacing said actuator from said operative engagement with saidpump assembly after sterilization such that said pump inlet and saidpump outlet can alternate between said open and said closed state todeliver the medication the patient.
 19. A system as set forth in claim18 wherein said actuator further comprises an actuation arm extendingfrom said base portion between said first and second engagement arms,said actuation arm being engaged by said plunger to displace saidactuator from said operative engagement with said pump assembly aftersterilization.
 20. A pump assembly for an integrated medication deliverysystem, wherein said pump assembly delivers medication to a patient andis suitable to prevent inadvertent delivery of the medication to thepatient, said assembly comprising: a pump housing having a pump inletand a pump outlet; a first pinch lever disposed at said pump inlet, saidfirst pinch lever being moveable between an open position and a closedposition to control a flow of the medication into said pump housingthrough said pump inlet; a second pinch lever disposed at said pumpoutlet, said second pinch lever being moveable between an open positionand a closed position to control a flow of the medication from said pumphousing through said pump outlet; a motor operatively engaging saidfirst and second pinch levers for moving said first and second pinchlevers into said open position such that the medication can be deliveredto the patient; and at least one biasing device engaging at least one ofsaid first and second pinch levers and working in conjunction with saidmotor to normally bias at least one of said first and second pinchlevers into said closed position during delivery of the medication tothe patient and to maintain at least one of said first and second pinchlevers in said closed position during a failure of said motor to preventthe inadvertent delivery of the medication to the patient.
 21. A pumpassembly as set forth in claim 20 further comprising a cam shaftsupported on said pump housing and geared to said motor to operativelyengage said motor with said first and second pinch levers.
 22. A pumpassembly as set forth in claim 21 wherein each of said first and secondpinch levers comprise a cam follower, said cam followers being engagedby said cam shaft for alternating movement of said first and secondpinch levers between said open and closed positions such that themedication can be delivered to the patient.
 23. A pump assembly as setforth in claim 20 further comprising a piston disposed in said pumphousing, said motor moving said piston within said pump housing to drawthe medication into said pump housing when said first pinch lever is insaid open position and said second pinch lever is in said closedposition, and to displace the medication from said pump housing whensaid first pinch lever is in said closed position and said second pinchlever is in said open position.
 24. A pump assembly as set forth inclaim 23 wherein said piston comprises an actuation end and a pumpingend with a diaphragm seal disposed at said pumping end.
 25. A pumpassembly as set forth in claim 24 wherein said actuation end of saidpiston comprises at least one slot, and said pump housing comprises atleast one detent engaging said at least one slot to prevent unwantedrotation of said piston as said piston is moved within said pump housingby said motor.
 26. A pump assembly as set forth in claim 24 wherein saidcam shaft supports first and second outside cams and an inside camdisposed between said first and second outside cams, said first outsidecam engaging said first pinch lever to move said first pinch leverbetween said open and closed position, said inside cam engaging saidactuation end of said piston to move said piston within said pumphousing, and said second outside cam engaging said second pinch lever tomove said second pinch lever between said open and closed positions. 27.A pump assembly as set forth in claim 26 wherein each of said first andsecond pinch levers comprise a cam follower, said cam follower of saidfirst pinch lever being engaged by said first outside cam foralternating movement of said first pinch lever between said open andclosed positions, and said cam follower of said second pinch lever beingengaged by said second outside cam for alternating movement of saidsecond pinch lever between said open and closed positions.
 28. A pumpassembly as set forth in claim 27 wherein each of said first and secondoutside cams comprise internal cam surfaces, said cam follower of saidfirst pinch lever riding within said internal cam surface of said firstoutside cam for alternating movement of said first pinch lever betweensaid open and closed positions, and said cam follower of said secondpinch lever riding within said internal cam surface of said secondoutside cam for alternating movement of said second pinch lever betweensaid open and closed positions.
 29. A pump assembly as set forth inclaim 26 further comprising an indicating flag extending from one ofsaid first and second outside cams for monitoring an amount of themedication that has been delivered to the patient.
 30. A pump assemblyas set forth in claim 29 in combination with a sensor optically-coupledwith said indicating flag to count revolutions of said indicating flagfor monitoring the amount of the medication that has been delivered tothe patient.
 31. A pump assembly as set forth in claim 20 wherein saidmotor moves said first and second pinch levers into said open positiondespite said bias of said at least one biasing device such that themedication can be delivered to the patient.
 32. A pump assembly as setforth in claim 20 in combination with; a medication inlet tube adaptedto provide access for the medication to flow into said pump inlet; and amedication outlet tube adapted to provide access for the medication toflow from said pump outlet; wherein said at least one biasing deviceengages said first pinch lever to normally-bias said first pinch leverinto said closed position to pinch said medication inlet tube, and saidat least one biasing device engages said second pinch lever tonormally-bias said second pinch lever into said closed position to pinchsaid medication outlet tube.
 33. A pump assembly as set forth in claim20 in combination with an actuator engaging said first and second pinchlevers to retain both said first and second pinch levers in said openposition for sterilization despite said bias of said at least onebiasing device.
 34. A pump assembly as set forth in claim 20 whereinsaid at least one biasing device is further defined as a compressionspring.
 35. A pump assembly as set forth in claim 20 wherein said atleast one biasing device comprises a first and a second biasing device,said first biasing device engaging said first pinch lever and saidsecond biasing device engaging said second pinch lever to maintain saidfirst and second pinch levers in said closed position during a failureof said motor to prevent the inadvertent delivery of the medication tothe patient.
 36. A pump assembly as set forth in claim 26 wherein eachof said first and second outside cams comprise a plurality of slitsalong an outer circumference of said cams to confirm dimensional tuningof said cams during assembly.
 37. A pump assembly as set forth in claim26 wherein at least one of said first and second outside cams comprisesan assembly slot defined within an outer circumference of said cams tofacilitate assembly of said pump assembly.
 38. A port assembly for anintegrated medication delivery system that includes a medicationreservoir and a pump assembly, wherein said port assembly enablesvarious fluids to flow into, from, and within the integrated medicationdelivery system, said port assembly comprising: an elongated housingcomprising a proximate end, a distal end, and an interior wall defininga fluid chamber between said ends, said proximate end of said housingextending from the integrated medication delivery system to provideaccess for the fluid to flow both into and from the integratedmedication delivery system; a first fluid connector extending from saidhousing for allowing the fluid to flow from said fluid chamber into thepump assembly; a second fluid connector extending from said housing forallowing the fluid to flow from the pump assembly into said fluidchamber; a third fluid connector extending from said housing forallowing the fluid to flow between said fluid chamber and the medicationreservoir; and a plunger disposed in said fluid chamber and beingmoveable in said fluid chamber between; an off-position where saidfirst, second, and third fluid connectors are isolated from saidproximate end of said housing by said plunger to prevent the flow offluid, a fill-position where said first and third fluid connectors arein fluid communication with said proximate end of said housing therebyproviding a fluid flow path between said proximate end of said housing,the medication reservoir, and the pump assembly such that the fluid canbe filled through said proximate end of said housing and into themedication reservoir and the pump assembly, and a fluiddelivery-position where said first, second, and third fluid connectorsare in fluid communication with said proximate end of said housing andwith each other for supplying the pump assembly and for delivering thefluid to a patient.
 39. A port assembly as set forth in claim 38 whereinsaid plunger comprises a length, a circumference, and a plurality ofseats disposed along said length and about said circumference, saidseats extending outwardly from said circumference to said interior wallof said housing for segregating said fluid chamber of said housing. 40.A port assembly as set forth in claim 39 further comprising a fluidpassage defined between each of said seats and said interior wall ofsaid housing for controlling the flow of fluid within said portassembly.
 41. A port assembly as set forth in claim 40 furthercomprising a seal disposed about each of said seats for sealing saidfluid passages from one another.
 42. A port assembly as set forth inclaim 41 further comprising at least one leak rib extending at leastpartially along said interior wall of said elongated housing toselectively cause at least one of said seals to leak when said plungeris in said fill-position.
 43. A port assembly as set forth in claim 41wherein said seals are O-rings.
 44. A port assembly as set forth inclaim 40 wherein said plunger is at least partially hollow to define aninternal fluid bore extending within said plunger between said seats.45. A port assembly as set forth in claim 44 wherein said plungerfurther comprises an access end and an actuation end, and said internalfluid bore extends from said access end, where the fluid flows into andfrom said internal fluid bore, toward said actuation end.
 46. A portassembly as set forth in claim 45 wherein said internal fluid borecomprises a fluid duct in fluid communication with one of said fluidpassages such that the fluid can flow into and from said internal fluidbore.
 47. A port assembly as set forth in claim 46 wherein saidplurality of seats are further defined as a first, second, third, andfourth seat, wherein said first seat is disposed toward said access endof said plunger, said fourth seat is disposed toward said actuation endof said plunger, and said second and third seats are disposedsuccessively between said first and fourth seats.
 48. A port assembly asset forth in claim 47 wherein said fluid passages are further defined asa first, second, and third fluid passage, wherein said first fluidpassage is defined between said first and second seats and said interiorwall, said second fluid passage is defined between said second and thirdseats and said interior wall, and said third fluid passage is definedbetween said third and fourth seats and said interior wall.
 49. A portassembly as set forth in claim 48 further comprising a first sealdisposed about said first seat for sealing said first fluid passage fromsaid access end of said plunger, a second seal disposed about saidsecond seat for sealing said first and second fluid passages from oneanother, a third seal disposed about said third seat for sealing saidsecond and third fluid passages from one another, and a fourth sealdisposed about said fourth seat for sealing said third fluid passagefrom said actuation end of said plunger.
 50. A port assembly as setforth in claim 49 further comprising at least one leak rib extendingalong said interior wall of said elongated housing from said proximateend toward said distal end to selectively cause said first seal to leakwhen said plunger is in said fill-position.
 51. A port assembly as setforth in claim 48 wherein said internal fluid bore extends within saidplunger from said access end to said third seat.
 52. A port assembly asset forth in claim 51 wherein said fluid duct is in fluid communicationwith said second fluid passage defined between said second and thirdseats and said interior wall such that the fluid can flow into and fromsaid internal fluid bore at said second fluid passage.
 53. A portassembly as set forth in claim 52 wherein said first, second, and thirdfluid connectors are isolated from said proximate end of said housingand from said access end of said plunger by said first, second, andthird seats when said plunger is in said off-position.
 54. A portassembly as set forth in claim 52 wherein said first and third fluidconnectors are in fluid communication with said proximate end of saidhousing and with said access end of said plunger through said secondfluid passage and said fluid duct of said internal fluid bore when saidplunger is in said fill-position such that the fluid can be filledthrough said access end of said plunger, through said internal fluidbore and said fluid duct, and into the medication reservoir and the pumpassembly.
 55. A port assembly as set forth in claim 54 wherein saidsecond fluid connector is isolated from said proximate end of saidhousing, from said access end of said plunger, and from said first andthird fluid connectors by said third and fourth seats when said plungeris in said fill-position.
 56. A port assembly as set forth in claim 52wherein said second fluid connector is in fluid communication with saidproximate end of said housing and with said access end of said plungerthrough said second fluid passage and said fluid duct of said internalfluid bore when said plunger is in said fluid delivery-position fordelivering the fluid from the pump assembly to the patient.
 57. A portassembly as set forth in claim 56 wherein said first and third fluidconnectors are isolated from said proximate end of said housing and saidaccess end of said plunger by said first and second seats, but are influid communication with the medication reservoir through said firstfluid passage when said plunger is in said fluid delivery-position forsupplying the pump assembly with the fluid.
 58. A port assembly as setforth in claim 48 wherein said first and third fluid connectors arealigned with said third fluid passage when said plunger is in saidoff-position, with said second fluid passage when said plunger is insaid fill-position, and with said first fluid passage when said plungeris in said fluid delivery-position.
 59. A port assembly as set forth inclaim 45 further comprising a biasing device disposed about saidactuation end of said plunger for biasing said plunger into saidoff-position.
 60. A port assembly as set forth in claim 38 incombination with a fluid filling device that engages said proximate endof said housing to automatically move said plunger into saidfill-position for filling the medication reservoir and the pumpassembly.
 61. A port assembly as set forth in claim 60 wherein saidfluid filling device is a syringe that moves said plunger into saidfill-position for filling the medication reservoir and the pumpassembly.
 62. A port assembly as set forth in claim 60 wherein saidfluid filling device is a fluid cap that moves said plunger into saidfill-position to enable a sterilization fluid to penetrate into themedication reservoir and the pump assembly.
 63. A port assembly as setforth in claim 45 in combination with a syringe engaging said access endof said plunger to automatically move said plunger into saidfill-position for filling the medication reservoir and the pump assemblythrough said internal fluid bore.
 64. A port assembly as set forth inclaim 38 in combination with an infusion tube set comprising a fluid endand a patient end wherein said fluid end of said tube set engages saidproximate end of said housing to automatically move said plunger intosaid fluid delivery-position for delivering the fluid to the patient.65. A port assembly as set forth in claim 45 in combination with aninfusion tube set comprising a fluid end and a patient end wherein saidfluid end of said tube set engages said access end of said plunger toautomatically move said plunger into said fluid delivery-position fordelivering the fluid to the patient.
 66. A blockage detection system foran integrated medication delivery system used for delivering medicationto a patient, wherein said blockage detection system detects a blockagein a flow of the medication to the patient and comprises: a basehousing; a medication reservoir disposed about said base housing forstoring the medication to be delivered to the patient; a port extendingfrom said base housing to provide access for the medication to flow tothe patient; a pump assembly supported by said base housing and in fluidcommunication with said medication reservoir for delivering themedication to the patient; a medication outlet tube mounted to said basehousing and connected between said pump assembly and said port toprovide access for the medication to flow from said pump assembly intosaid port and to the patient, wherein said outlet tube has a diameterthat is contractible and expandable between a normal condition and anexpanded condition in response to variations in pressure resulting fromthe flow of the medication from said medication reservoir through saidpump assembly into said port and to the patient; an electroniccontroller mounted to said base housing adjacent said outlet tube; and adetection film disposed between said electronic controller and saidoutlet tube, said detection film being in contact with said outlet tubeand remaining spaced from said electronic controller when said diameterof said outlet tube is in said normal condition, and said detection filmbeing in contact with said outlet tube and contacting said electroniccontroller to activate said electronic controller when said diameter ofsaid outlet tube is in said expanded condition in response to increasedpressure resulting from the blockage in the flow of the medication tothe patient.
 67. A blockage detection system as set forth in claim 66wherein said detection film is mounted to said electronic controller,yet remains at least partially-spaced from said electronic controllerwhen said diameter of said outlet tube is in said normal condition. 68.A blockage detection system as set forth in claim 67 further comprisingan adhesive layer for mounting said detection film to said electroniccontroller and for spacing said detection film from said electroniccontroller when said diameter of said outlet tube is in said normalcondition.
 69. A blockage detection system as set forth in claim 66further comprising a support platform mounted on said base housing forsupporting said outlet tube on said base housing.
 70. A blockagedetection system as set forth in claim 69 wherein said support platformcomprises at least one tube slot to house said diameter of said outlettube.
 71. A blockage detection system as set forth in claim 70 whereinsaid outlet tube is mounted in said tube slot such that at least aportion of said diameter of said outlet tube is exposed to saiddetection film.
 72. A blockage detection system as set forth in claim 66wherein said detection film is conductive for activating said electroniccontroller when said diameter of said outlet tube is in said expandedcondition.
 73. A blockage detection system as set forth in claim 66wherein said electronic controller deactivates said pump assembly toprevent delivery of the medication to the patient when said diameter ofsaid outlet tube is in said expanded condition due to blockage in theflow of the medication to the patient.
 74. A blockage detection systemas set forth in claim 66 further comprising an alarm activated by saidelectronic controller to indicate the blockage when said diameter ofsaid outlet tube is in said expanded condition due to blockage in theflow of the medication to the patient.
 75. A blockage detection systemas set forth in claim 66 further comprising an electronic switchembedded in said electronic controller between said electroniccontroller and said detection film wherein said detection film contactssaid electronic switch to activate said electronic controller when saiddiameter of said outlet tube is in said expanded condition.
 76. Ablockage detection system as set forth in claim 66 wherein saidelectronic controller deactivates said pump assembly when said diameterof said outlet tube is in said expanded condition for more than at leastone cycle of said pump assembly.
 77. A blockage detection system for anintegrated medication delivery system used for delivering medication toa patient, wherein said blockage detection system detects a blockage ina flow of the medication to the patient and comprises: a base housing; amedication reservoir disposed about said base housing for storing themedication to be delivered to the patient; a port extending from saidbase housing to provide access for the medication to flow to thepatient; a pump assembly supported by said base housing and in fluidcommunication with said medication reservoir for delivering themedication to the patient; an electronic controller mounted to said basehousing; a medication outlet tube mounted to said base housing andconnected between said pump assembly and said port to provide access forthe medication to flow from said pump assembly into said port and to thepatient, wherein said outlet tube has a diameter that is contractibleand expandable between a normal condition, where said outlet tube isspaced from said electronic controller, and an expanded condition, wheresaid outlet tube is in contact with said electronic controller, inresponse to variations in pressure resulting from the flow of themedication from said medication reservoir through said pump assemblyinto said port and to the patient; and a coating applied to said outlettube, said coating activating said electronic controller when saiddiameter of said outlet tube is in said expanded condition in responseto increased pressure resulting from the blockage in the flow of themedication to the patient.
 78. A blockage detection system as set forthin claim 76 wherein said coating is conductive.
 79. A blockage detectionsystem as set forth in claim 77 wherein said coating that is applied tosaid outlet tube is formed of conductive carbon.
 80. A blockagedetection system as set forth in claim 76 further comprising a supportplatform mounted on said base housing for supporting said outlet tube onsaid base housing.
 81. A blockage detection system as set forth in claim79 wherein said support platform comprises at least one tube slot tohouse said diameter of said outlet tube.
 82. A blockage detection systemas set forth in claim 80 wherein said outlet tube is mounted in saidtube slot such that at least a portion of said coating is exposed beyondsaid tube slot.
 83. A blockage detection system as set forth in claim 76wherein said electronic controller deactivates said pump assembly toprevent delivery of the medication to the patient when said diameter ofsaid outlet tube is in said expanded condition due to blockage in theflow of the medication to the patient.
 84. A blockage detection systemas set forth in claim 76 further comprising an alarm activated by saidelectronic controller to indicate the blockage when said diameter ofsaid outlet tube is in said expanded condition due to blockage in theflow of the medication to the patient.
 85. A blockage detection systemas set forth in claim 76 further comprising an electronic switchembedded in said electronic controller that is activated when saiddiameter of said outlet tube is in said expanded condition in responseto increased pressure resulting from the blockage in the flow of themedication to the patient.
 86. A blockage detection system as set forthin claim 77 wherein said electronic controller deactivates said pumpassembly when said diameter of said outlet tube is in said expandedcondition for more than at least one cycle of said pump assembly.
 87. Anempty detection system for an integrated medication delivery system usedfor delivering medication to a patient, wherein said empty detectionsystem determines when a supply of the medication has been depleted andcomprises: a base housing; a medication reservoir disposed about saidbase housing for storing the supply of the medication to be delivered tothe patient; a port extending from said base housing to provide accessfor the medication to flow to the patient; a pump assembly supported bysaid base housing and in fluid communication with said medicationreservoir for delivering the medication to the patient; a medicationinlet tube mounted to said base housing and connected between saidmedication reservoir and said pump assembly to provide access for themedication to flow from said medication reservoir into said pumpassembly and to the patient, wherein said inlet tube has a diameter thatis contractible and expandable between a normal condition and acollapsed condition in response to variations in pressure resulting froma lack of flow of the medication from said medication reservoir intosaid pump assembly and to the patient; an electronic controller mountedto said base housing adjacent said inlet tube; and a detection filmdisposed between said electronic controller and said inlet tube, saiddetection film being in contact with said inlet tube and contacting saidelectronic controller to activate said electronic controller when saiddiameter of said inlet tube is in said normal condition, and saiddetection film becoming spaced from said electronic controller todeactivate said electronic controller when said diameter of said inlettube is in said collapsed condition in response to the lack of flow ofthe medication resulting from the supply of the medication beingdepleted.
 88. An empty detection system as set forth in claim 87 furthercomprising an electronic switch embedded in said electronic controllerbetween said electronic controller and said detection film, wherein saiddetection film contacts said electronic switch to activate saidelectronic controller when said diameter of said inlet tube is in saidnormal condition and said detection film becomes spaced from saidelectronic switch to deactivate said electronic controller when saiddiameter of said inlet tube is in said collapsed condition.
 89. An emptydetection system as set forth in claim 88 wherein said detection filmcomprises a film base portion and a cantilever portion extending fromsaid film base portion to contact said electronic switch in said normalcondition.
 90. An empty detection system as set forth in claim 89wherein said film base portion of said detection film is mounted to saidelectronic controller away from said electronic switch.
 91. An emptydetection system as set forth in claim 89 wherein said cantileverportion of said detection film becomes spaced from said electroniccontroller to deactivate said electronic controller when said diameterof said inlet tube is in said collapsed condition.
 92. An emptydetection system as set forth in claim 87 further comprising a supportplatform mounted on said base housing for supporting said inlet tube onsaid base housing.
 93. An empty detection system as set forth in claim92 wherein said support platform comprises at least one tube slot tohouse said diameter of said inlet tube.
 94. An empty detection system asset forth in claim 93 wherein said inlet tube is mounted in said tubeslot such that at least a portion of said diameter of said inlet tube isexposed to said detection film.
 95. An empty detection system as setforth in claim 87 wherein said detection film is conductive foractivating said electronic controller when said diameter of said inlettube is in said normal condition.
 96. An empty detection system as setforth in claim 87 further comprising an alarm activated by saidelectronic controller to indicate the lack of flow of the medicationwhen said diameter of said inlet tube is in said collapsed condition dueto the lack of flow of the medication to the patient.
 97. An emptydetection system as set forth in claim 87 wherein said electroniccontroller deactivates said pump assembly when said diameter of saidinlet tube is in said collapsed condition due to the lack of flow of themedication to the patient.
 98. An empty detection system as set forth inclaim 87 wherein said electronic controller deactivates said pumpassembly when said diameter of said inlet tube is in said collapsedcondition for more than at least one cycle of said pump assembly.
 99. Anempty detection system for an integrated medication delivery system usedfor delivering medication to a patient, wherein said empty detectionsystem determines when a supply of the medication has been depleted andcomprises: a base housing; a medication reservoir disposed about saidbase housing for storing the supply of the medication to be delivered tothe patient; a port extending from said base housing to provide accessfor the medication to flow to the patient; a pump assembly supported bysaid base housing and in fluid communication with said medicationreservoir for delivering the medication to the patient; an electroniccontroller mounted to said base housing; a medication inlet tube mountedto said base housing and connected between said medication reservoir andsaid pump assembly to provide access for the medication to flow fromsaid medication reservoir into said pump assembly and to the patient,wherein said inlet tube has a diameter that is contractible andexpandable between a normal condition, where said inlet tube is incontact with said electronic controller, and a collapsed condition,where said inlet tube becomes spaced from said electronic controller, inresponse to variations in pressure resulting from a lack of flow of themedication from said medication reservoir into said pump assembly and tothe patient; and a coating applied to said inlet tube, said coatingcontacting said electronic controller to activate said electroniccontroller when said diameter of said inlet tube is in said normalcondition, and said coating becoming spaced from said electroniccontroller to deactivate said electronic controller when said diameterof said inlet tube is in said collapsed condition in response to thelack of flow of the medication resulting from the supply of themedication being depleted.
 100. An empty detection system as set forthin claim 99 wherein said coating is conductive.
 101. An empty detectionsystem as set forth in claim 100 wherein said coating that is applied tosaid outlet tube is formed of conductive carbon.
 102. An empty detectionsystem as set forth in claim 99 further comprising an electronic switchembedded in said electronic controller that is activated when saiddiameter of said inlet tube is in said normal condition and that isdeactivated when said inlet tube is in said collapsed condition.
 103. Anempty detection system as set forth in claim 99 further comprising asupport platform mounted on said base housing for supporting said inlettube on said base housing.
 104. An empty detection system as set forthin claim 103 wherein said support platform comprises at least one tubeslot to house said diameter of said inlet tube.
 105. An empty detectionsystem as set forth in claim 104 wherein said inlet tube is mounted insaid tube slot such that at least a portion of said coating is exposedbeyond said tube slot.
 106. An empty detection system as set forth inclaim 99 further comprising an alarm activated by said electroniccontroller to indicate the lack of flow of the medication when saiddiameter of said inlet tube is in said collapsed condition due to thelack of flow of the medication to the patient.
 107. An empty detectionsystem as set forth in claim 99 wherein said electronic controllerdeactivates said pump assembly when said diameter of said inlet tube isin said collapsed condition due to the lack of flow of the medication tothe patient.
 108. An empty detection system as set forth in claim 99wherein said electronic controller deactivates said pump assembly whensaid diameter of said inlet tube is in said collapsed condition for morethan one cycle of said pump assembly.
 109. An integrated medicationdelivery system for delivering medication to a patient wherein theoperation of said system can be tested using a testing instrument afterassembly of said system, and said system can be completely sterilized bya sterilization fluid after testing, said system comprising: a basehousing; a medication reservoir disposed about said base housing forstoring the medication to be delivered to the patient; a pump assemblysupported by said base housing for delivering the medication to thepatient, said pump assembly comprising a pump housing having a pumpinlet and a pump outlet, wherein said pump inlet and said pump outletalternate between an open and a closed state to deliver the medicationthe patient; a port extending from said base housing, said port being influid communication with said medication reservoir and said pumpassembly during sterilization to provide access for the sterilizationfluid to flow into said medication reservoir and said pump assembly; anactuator disposed in said base housing wherein said actuator is moveablebetween; a disengaged position wherein said actuator is operativelydisengaged from said pump inlet and said pump outlet to permit said pumpinlet and said pump outlet to alternate between said open and closedstates after assembly and during testing of the system, and an engagedposition where said actuator is operatively engaged to said pump inletand said pump outlet to retain both said pump inlet and said pump outletin said open state during sterilization such that the sterilizationfluid can penetrate into said medication reservoir, said pump inlet,said pump housing, and said pump outlet to completely sterilize saidsystem; and at least one testing access port defined within said basehousing and aligned with at least one of said pump inlet, said pumpoutlet, and said actuator to provide access for the testing instrumentto move said actuator between said disengaged position and said engagedposition such that said pump inlet and said pump outlet can alternatebetween said open and closed states after assembly and during testing ofsaid system, and such that said pump inlet and said pump outlet can beretained in said open state after said system has been tested to preparesaid system for sterilization.
 110. A system as set forth in claim 109wherein said at least one testing access port is further defined asfirst, second, and third testing access ports wherein said first testingaccess port is aligned with said pump inlet, said second testing accessport is aligned with said pump outlet, and said third testing accessport is aligned with said actuator for providing access to the testinginstrument to move said actuator into said engaged position.
 111. Asystem as set forth in claim 110 further comprising a first pinch leverdisposed at said pump inlet that is normally-biased to maintain saidpump inlet in said closed state, and a second pinch lever disposed atsaid pump outlet that is normally-biased to maintain said pump outlet insaid closed state.
 112. A system as set forth in claim 111 wherein saidfirst testing access port is aligned with said first pinch lever suchthat said first pinch lever is adapted to be engaged by the testinginstrument thereby forcing said first pinch lever away from said pumpinlet and said pump inlet into said open state, and said second testingaccess port is aligned with said second pinch lever such that saidsecond pinch lever is adapted to be engaged by the testing instrumentthereby forcing said second pinch lever away from said pump outlet andsaid pump outlet into said open state.
 113. A system as set forth inclaim 112 wherein said actuator is moved into said engaged positionafter said first and second pinch levers have been forced away from saidpump inlet and said pump outlet, respectively, by the testinginstrument.
 114. A system as set forth in claim 112 wherein each of saidfirst and second pinch levers comprise lever guides that are adapted tobe engaged by the testing instrument upon insertion of the testinginstrument into said first and second testing access ports.
 115. Asystem as set forth in claim 109 further comprising a first pinch leverdisposed at said pump inlet that is normally-biased to maintain saidpump inlet in said closed state, and a second pinch lever disposed atsaid pump outlet that is normally-biased to maintain said pump outlet insaid closed state.
 116. A system as set forth in claim 115 wherein saidactuator is operatively disengaged from said first and second pinchlevers in said disengaged position such that said pump inlet and saidpump outlet can alternate between said open and closed states afterassembly and during testing of the system.
 117. A system as set forth inclaim 116 wherein said actuator is operatively engaged to said first andsecond pinch levers in said engaged position such that said pump inletand said pump outlet are retained in said open state duringsterilization and after said system has been tested.
 118. A system asset forth in claim 117 wherein said at least one testing access port isaligned with at least one of said first pinch lever, said second pinchlever, and said actuator to provide access for the testing instrument tomove said actuator between said disengaged position and said engagedposition.
 119. A system as set forth in claim 116 wherein said actuatorcomprises a base portion and at least one engagement arm extending fromsaid base portion with said at least one engagement arm of said actuatoroperatively engaging and disengaging said first and second pinch levers.120. A system as set forth in claim 119 wherein said at least onetesting access port is aligned with said at least one engagement arm ofsaid actuator to provide access for the testing instrument to move saidactuator between said disengaged position and said engaged position.121. A system as set forth in claim 119 wherein said at least oneengagement arm is further defined as a first and second engagement armwith said first engagement arm of said actuator operatively engaging anddisengaging said first pinch lever, and said second engagement arm ofsaid actuator operatively engaging and disengaging said second pinchlever.
 122. A system as set forth in claim 109 further comprising aplunger disposed within said port to displace said actuator from saidengaged position such that said pump inlet and said pump outlet canalternate between said open and closed state to deliver the mediation tothe patient after assembly, testing, and sterilization of said system.123. A system as set forth in claim 109 further comprising a motor andan electronic controller mounted to said base housing for controlling anamount of the medication to be delivered to the patient.
 124. A systemas set forth in claim 123 further comprising at least one controlleraccess port defined within said base housing and aligned with saidelectronic controller to provide access for a second testing instrumentthat causes said electronic controller to activate said motor such thatsaid motor is powered to alternate said pump inlet and said pump outletbetween said open and closed states after assembly and during testing ofthe system.
 125. An integrated medication delivery system for deliveringmedication to a patient wherein said system is suitable for carrying bythe patient and comprises: a base housing; a carrying strap mountedwithin said base housing for the carrying of said system by the patient;a medication reservoir disposed about said base housing for storing themedication to be delivered to the patient; a pump assembly supported bysaid base housing for delivering the medication to the patient, saidpump assembly comprising a pump housing having a pump inlet and a pumpoutlet, wherein said pump inlet and said pump outlet alternate betweenan open and a closed state to deliver the medication the patient; a portextending from said base housing, said port being in fluid communicationwith said medication reservoir, said pump assembly, and the patient toprovide access for the medication to be delivered to the patient; and anintegral storage cavity defined within said base housing wherein saidcarrying strap is at least partially disposed in said integral storagecavity and at least partially extends from said integral storage cavityto interact with the patient for carrying said system.
 126. A system asset forth in claim 125 wherein said base housing is further defined as abottom housing and a top housing mounted to said bottom housing.
 127. Asystem as set forth in claim 126 further comprising a reservoir casingdisposed between said bottom and top housings, said reservoir casing atleast partially surrounding said medication reservoir to protect themedication to be delivered to the patient as the patient carries saidsystem.
 128. A system as set forth in claim 126 further comprising aplurality of cavity walls extending from said bottom housing to definesaid integral storage cavity between said bottom and top housings. 129.A system as set forth in claim 128 wherein said plurality of cavitywalls is further defined as a front wall, a rear wall, and first andsecond side walls extending between said front and rear walls to supportsaid front and rear walls and to define said integral storage cavity.130. A system as set forth in claim 129 further comprising at least onestrap slot defined within said front wall such that at least a portionof said carrying strap extends from said integral storage cavity throughsaid strap slot for access of said portion by the patient when desired.131. A system as set forth in claim 130 wherein the patient manipulatessaid portion of said carrying strap to pull a length of said carryingstrap from said integral storage cavity.
 132. A system as set forth inclaim 131 wherein said carrying strap is retractable into said integralstorage cavity after said length has been pulled from said integralstorage cavity by the patient.
 133. A system as set forth in claim 125further comprising a clip connecting opposing ends of said carryingstrap such that said carrying strap is adjustable.
 134. A system as setforth in claim 125 in combination with a system mounting clip extendingfrom an exterior facing of said base housing that is adapted to bemounted to a belt of the patient.
 135. A system as set forth in claim125 wherein said carrying strap is further defined as a shoulder strapthat is adapted to suspend from a shoulder of the patient for carryingsaid system.
 136. A method of controlling an integrated medicationdelivery system that is used to deliver medication to a patient whereinthe system includes an electronic controller, at least one controlbutton, a patient label, and a removable overlay label disposed on topof the patient label for controlling an amount of the medication to bedelivered to the patient, said method comprising the steps of: selectingthe amount of the medication in accordance with a first set ofexplanatory indicia on the removable overlay label; locking the systemsuch that the selected amount of the medication to be delivered to thepatient is unable to be modified; removing the removable overlay labelto reveal the patient label; and operating the system in accordance witha second set of explanatory indicia on the patient label.
 137. A methodas set forth in claim 136 wherein the step of operating the system inaccordance with the second set of explanatory indicia comprises the stepof deactivating the system to stop delivery of the medication to thepatient.
 138. A method as set forth in claim 137 wherein the step ofoperating the system in accordance with the second set of explanatoryindicia further comprises the step of activating the system to re-startdelivery of the medication to the patient after the system has beendeactivated.
 139. A method as set forth in claim 136 wherein the step ofoperating the system in accordance with the second set of explanatoryindicia comprises the step of requesting an additional amount of themedication relative to the selected amount.
 140. A method as set forthin claim 139 wherein the step of requesting an additional amount of themedication relative to the selected amount is further defined asactuating the control button to request the additional amount of themedication.
 141. A method as set forth in claim 136 wherein the step ofselecting the amount of the medication is further defined as selecting aflow rate for the medication.
 142. A method as set forth in claim 136wherein the step of locking the system comprises the step of modifying afunctionality of the control button such that the functionality of thecontrol button is different when the removable overlay label isdisplayed on the system as compared to when the patient label isdisplayed on the system.
 143. A method as set forth in claim 142 whereinthe control button is at least tri-functional when the removable overlaylabel is displayed on the system and the step of modifying thefunctionality of the control button is further defined as converting thefunctionality of the control button from at least tri-functional tobi-functional after the system has been locked and the patient label isdisplayed on the system.
 144. A method as set forth in claim 136 whereinthe system further includes an electronic display that presents areadable output and said method further comprises the step ofcorrelating the readable output of the electronic display with theremovable overlay label and the patient label.
 145. A method as setforth in claim 144 wherein the step of correlating the readable outputof the electronic display is further defined as presenting a firstreadable output linked with the first set of explanatory indicia whenthe removable overlay label is displayed, and presenting a secondreadable output linked with the second set of explanatory indicia afterthe system has been locked.
 146. A method as set forth in claim 136further comprising the steps of mounting the patient label to the systemand mounting the removable overlay label on top of the patient label toat least partially cover the patient label.
 147. A control system for anintegrated medication delivery system, the integrated medicationdelivery system having a pump assembly, the pump assembly including apump housing and a motor for delivering medication to a patient, thecontrol system comprising: an electronic controller for controllingoperation of the integrated medication delivery system; a motor controlcircuit having a first switch and being coupled between the electroniccontroller and the motor, the first switch having an open state and aclosed state; and, a watchdog circuit coupled to the electroniccontroller, the watchdog circuit including a monitor circuit and asecond switch, the second switch having an open state and a closed stateand being coupled to the first switch, wherein the monitor circuit isadapted to detect an abnormal condition in the control system and toresponsively turn the second switch off if the abnormal condition isdetected, and wherein the motor control circuit is adapted to receivecontrol signals from the electronic controller and to responsivelysupply power to the motor by placing the first switch in one of the openand closed states, wherein power is supplied to the motor if the firstand second switches are in the closed state.
 148. A control system, asset forth in claim 147, wherein the first switch is a field effecttransistor.
 149. A control system, as set forth in claim 147, whereinthe second switch is a field effect transistor.
 150. A control system,as set forth in claim 147, wherein the electronic controller includes amicroprocessor.
 151. A control system, as set forth in claim 147,including at least one control button coupled to the electroniccontroller and being adapted to receive a desired flow rate from a user.152. A control system, as set forth in claim 151, wherein the electroniccontroller is adapted to receive the desired flow rate and torespectively control energization of the motor to deliver medication atthe desired flow rate.
 153. A control system, as set forth in claim 152,wherein a revolution of the motor delivers a set amount of medication,and wherein the electronic controller calculates an amount of timebetween each revolution of the motor as a function of the desired flowrate.
 154. A control system, as set forth in claim 153, wherein themotor control circuit includes a motor sensor coupled to the motor andbeing adapted to detect a revolution of the motor and to responsivelygenerate a motor revolution signal in response to completion of themotor revolution.
 155. A control system, as set forth in claim 154,wherein the electronic controller is adapted to reset the watchdogcircuit prior to sending control signals to the motor control circuit toenergize the motor and wherein the watchdog circuit is adapted to placethe second switch in the closed state if two motor revolution signalsare received without the watchdog circuit being reset.
 156. A controlsystem, as set forth in claim 155, wherein the monitor circuit includesfirst and second flip-flops, the first flip-flop being coupled to theelectronic controller and the second flip-flop, and the second flip-flopbeing coupled to the second switch.
 157. A control system, as set forthin claim 156, wherein the electronic controller supplies power to thefirst and second flip-flops.
 158. A control system, as set forth inclaim 157, wherein the electronic controller shuts off power to thefirst and second flip-flops between revolutions of the motor.
 159. Acontrol system, as set forth in claim 157, wherein the electroniccontroller resets the watchdog circuit by shutting off and restoringpower to the first and second flip-flops.
 160. A control system, as setforth in claim 154, wherein the electronic controller is adapted totrack a time after a motor control signal has been sent and to enter adisabled state if the time between the sent motor control signal and thereceived motor revolution signal exceeds a predetermined threshold. 161.A control system, as set forth in claim 147, further comprising a keywhich is adapted to be coupled to the electronic controller only duringinitial start-up and wherein the electronic controller is adapted toinitialize upon start-up only if the key is present.
 162. A controlsystem, as set forth in claim 147, wherein the electronic controllerincludes a microprocessor and a crystal coupled to the microprocessorand the microprocessor includes an internal oscillator, wherein theelectronic controller is adapted to compare a first frequency associatedwith the internal oscillator and a second frequency associated with theinternal oscillator.
 163. A control system, as set forth in claim 162,wherein the electronic controller is adapted to compare a differencebetween the first and second frequencies and enter a disabled state ifthe difference is greater than a predetermined threshold.
 164. A circuitfor use in a control system for an integrated medication deliverysystem, the integrated medication delivery system having a pumpassembly, the pump assembly including a pump housing and a motor fordelivering medication to a patient, the circuit comprising: a motorcontrol circuit having a first switch and being coupled between theelectronic controller and the motor, the first switch having an openstate and a closed state; and, a watchdog circuit coupled to theelectronic controller, the watchdog circuit including a monitor circuitand a switch, the second switch having an open state and a closed stateand being coupled to the first switch, wherein the monitor circuit isadapted to detect an abnormal condition in the control system and toresponsively turn the second switch off if the abnormal condition isdetected, and wherein the motor control circuit is adapted to receivecontrol signals from the electronic controller and to responsivelysupply power to the motor by placing the first switch in one of the openand closed states, wherein power is supplied to the motor if the firstand second switches are in the closed state.
 165. A circuit, as setforth in claim 164, wherein the first switch is a field effecttransistor.
 166. A circuit, as set forth in claim 164, wherein thesecond switch is a field effect transistor.
 167. A circuit, as set forthin claim 164, wherein the motor control circuit includes a motor sensorcoupled to the motor and being adapted to detect a revolution of themotor and to responsively generate a motor revolution signal in responseto completion of the motor revolution.
 168. A circuit, as set forth inclaim 167, wherein the electronic controller is adapted to reset thewatchdog circuit prior to sending control signals to the motor controlcircuit to energize the motor and wherein the watchdog circuit isadapted to place the second switch in the open state if two motorrevolution signals are received without the watchdog circuit beingreset.
 169. A circuit, as set forth in claim 168, wherein the monitorcircuit includes first and second flip-flops, the first flip-flop beingcoupled to the electronic controller and the second flip-flop, and thesecond flip-flop being coupled to the second switch.
 170. A circuit, asset forth in claim 169, wherein the electronic controller supplies powerto the first and second flip-flops.
 171. A circuit, as set forth inclaim 170, wherein the electronic controller shuts off power to thefirst and second flip-flops between revolutions of the motor.
 172. Acircuit, as set forth in claim 170, wherein the electronic controllerresets the watchdog circuit by shutting off and restoring power to thefirst and second flip-flops.
 173. A circuit, as set forth in claim 164,further comprising a key which is adapted to be coupled to theelectronic controller only during initial start-up and wherein theelectronic controller is adapted to initialize upon start-up only if thekey is present.
 174. A circuit, as set forth in claim 173, wherein theelectronic controller includes a microprocessor and a crystal coupled tothe microprocessor and the microprocessor includes an internaloscillator, wherein the electronic controller is adapted to compare afirst frequency associated with the internal oscillator and a secondfrequency associated with the internal oscillator.
 175. A circuit, asset forth in claim 174, wherein the electronic controller is adapted tocompare a difference between the first and second frequencies and entera disabled state if the difference is greater than a predeterminedthreshold.
 176. A control system for an integrated medication deliverysystem, comprising: an electronic controller for controlling operationof the integrated medication delivery system; and, a key which isadapted to be coupled to the electronic controller only during initialstart-up and wherein the electronic controller is adapted to initializeupon start-up only if the key is present.
 177. A control system for anintegrated medication delivery system, comprising: an electroniccontroller for controlling operation of the integrated medicationdelivery system, the electronic controller including a microprocessorhaving an internal oscillator; and, a crystal coupled to themicroprocessor, wherein the electronic controller is adapted to comparea first frequency associated with the internal oscillator and a secondfrequency associated with the internal oscillator.
 178. A controlsystem, as set forth in claim 177, wherein the electronic controller isadapted to compare a difference between the first and second frequenciesand enter a disabled state if the difference is greater than apredetermined threshold.